Clinical Trials
Ongoing
GPS: Ongoing Clinical Trials:
Acute Myeloid Leukemia (AML)
Phase 3 Trial (REGAL Study) of GPS Monotherapy in AML Patients in CR2 (NCT04229979)
Phase 3 Trial (REGAL Study) of GPS Monotherapy in AML Patients in CR2 (NCT04229979)
Trial Status: Currently enrolling
- For AML patients who have achieved second or later morphologic complete remission, with or without thrombocytopenia (Second Complete Remission [CR2]/CR2p), after second line antileukemic therapy and who are ineligible for or unable to undergo Allogeneic Stem Cell Transplantation (ASCT).
- 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators’ choice of best available treatment.
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- Primary endpoint: overall survival (OS) from time of study entry.
- Secondary endpoints: leukemia free survival, antigen specific T-cell immune response dynamics, measurable residual disease by multi-gene array, assessments of AML clonal evolution and inflammasome molecular signatures in the tumor.
- Expected to enroll approximately 125-140 patients across approximately 95 clinical sites in the US, Europe and Asia.
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For full trial information, please visit ClinicalTrials.gov
SLS009 Ongoing Clinical Trials:
Acute Myeloid Leukemia (AML)
Phase 2a Trial of SLS009 in combination with venetoclax and azacytidine (aza/ven) in patients with relapsed/refractory (r/r) AML who did not respond or stopped responding to venetoclax-based therapies (NCT04588922)
Phase 2a Trial of SLS009 in combination with venetoclax and azacytidine (aza/ven) in patients with relapsed/refractory (r/r) AML who did not respond or stopped responding to venetoclax-based therapies (NCT04588922)
Trial Status: Currently enrolling
- Open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels of SLS009 and three treatment regimens (SLS009 45 mg once weekly; SLS009 60 mg once weekly; or SLS009 30 mg twice weekly) in combination with aza/ven.
- Will enroll up to 30 r/r AML patients, up to 10 patients per dosing regimen, all of whom will receive SLS009 in combination with standard doses of aza/ven. All patients are relapsed after or refractory to venetoclax combination therapies, including aza/ven.
- Primary endpoints: safety, tolerability, and composite complete response rate (CRc) and duration of response (DOR).
- Additional endpoints: event free survival (EFS), overall survival (OS), and pharmacokinetic (PK), and pharmacodynamic (PD) assessments.
For full trial information, please visit ClinicalTrials.gov
Peripheral T-Cell Lymphoma (PTCL)
A Study of GFH009 Monotherapy in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
A Study of GFH009 Monotherapy in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Trial Status: Currently enrolling
- Multi-center, open-label phase Ib/II study in China. Designed to assess the efficacy, safety/tolerability and pharmacokinetics of SLS009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma. Sponsored and fully funded by GenFleet Therapeutics.
- Will enroll up to 95 patients in two stages, first stage enrollment up to 25 patients.
- Primary endpoint: Objective Response Rate (ORR).
- Additional endpoints: Duration of Response (DOR), safety/toxicity, and Pharmacokinetics (PK).
Completed
GPS Completed Clinical Trials:
Acute Myeloid Leukemia (AML)
Phase 2 trial of GPS monotherapy in AML patients in first complete remission (CR1)
Phase 2 trial of GPS monotherapy in AML patients in second complete remission (CR2)
Phase 2 trial of GPS monotherapy in AML patients in first complete remission (CR1)
Phase 2 trial of GPS monotherapy in AML patients in second complete remission (CR2)
- Median Overall Survival (OS): 67.6 mo. (all ages) for patients receiving GPS in maintenance setting.
- Substantial improvement compared to best standard therapies.
- Patient median age: 63 years old.
- Results showed trend in improved clinical outcomes in patients who mounted an immune response with GPS compared to those who did not (Maslak PG, et al. Blood Adv. 2018;2:224-34).
- Initial data: median OS of 16.3 months (all ages) vs. 5.4 mo. in post-hoc matched, contemporaneously treated patients (P = 0.0175) (Brayer J, et al. Am J Hematol. 2015;90:602-7).
- Final data:
- Median OS of 21 months at median follow-up of 30.8 months in patients receiving GPS therapy vs. 5.4 months OS for those AML CR2 patients treated with best standard care.
- Statistically significant difference (p-value < 0.02) for patients treated with GPS.
- Serial active immunization with GPS showed well-tolerated safety profile.
- GPS elicited immune responses in patients, including CD4+ and CD8+ T cell responses.
Ovarian Cancer
Open-label, non-randomized Phase 1/2 clinical study evaluated the safety and efficacy of GPS in combination with nivolumab (Opdivo®), a PD-1 immune checkpoint inhibitor, in patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who are in second or greater clinical remission
Open-label, non-randomized Phase 1/2 clinical study evaluated the safety and efficacy of GPS in combination with nivolumab (Opdivo®), a PD-1 immune checkpoint inhibitor, in patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who are in second or greater clinical remission
- Enrolled 11 patients with recurrent ovarian cancer in second or greater clinical remission at MSKCC. 10 patients were evaluable.
- Patients enrolled received combination therapy during 14-week treatment period.
- Those who have not progressed by end of the period also received maintenance course of GPS.
- Repeated vaccination with GPS for 6 inoculations in combination with 7 infusions of nivolumab shown not to add toxicity burden above and beyond what is expected with nivolumab alone.
- Primary endpoint of study (safety of combination) was met.
- 1-year landmark progression free survival (PFS) rate: 70% for patients who received > 2 doses of GPS and nivolumab (n=10).
- Compared favorably with historical rate of 43-50% in this setting (O’Cearhaill RE, et al. J Clin Oncol. 2018;36 [15; Suppl], 5553).
- Median follow-up of 33 months: 30% of patients being progression free at 2 years (historical controls: 3-10%).
- WT1-specific IgG observed in 86% of patients (weeks 27) and CD4 and CD8 T cell responses.
- Data supported rationale for further study of GPS in combination with PD1 inhibitors in patients with advanced ovarian cancer.
Ovarian Cancer
Phase 1/2 trial of GPS in combination with pembrolizumab (Keytruda®) in WT1(+) relapsed or refractory platinum-resistant advanced metastatic ovarian cancer (NCT03761914)
Phase 1/2 trial of GPS in combination with pembrolizumab (Keytruda®) in WT1(+) relapsed or refractory platinum-resistant advanced metastatic ovarian cancer (NCT03761914)
- Median overall survival (OS): 18.4 months compared to 13.8 months in a checkpoint inhibitor single agent study in a similar patient population treated with a checkpoint inhibitor alone.
- Median progression-free survival (PFS): 12 weeks compared to 8 weeks in a checkpoint inhibitor single agent study in a similar patient population treated with a checkpoint inhibitor alone.
- Overall response rate (ORR): 6.3%.
- Disease control rate (DCR) (sum of overall response rate [ORR] and rate of stable disease): 50.1% at a median follow-up of 14.4 months.
- In checkpoint inhibitor single agent study in similar patients treated with checkpoint inhibitor alone, DCR was 37.2%.
- DCR rate increase of 45% in GPS combination with pembrolizumab over that seen for checkpoint inhibitors alone.
- Survival and disease control benefits observed in patients harboring tumors with any level of detectable PD-L1 expression (Combined Positive Score [CPS] of 1 or higher).
- DCR: 63.6% in patients with a CPS of 1 or higher.
- In 16 evaluable patients, correlation observed between PFS and OS and WT1-specific immune response after GPS vaccination across more than 1 channel with intracellular cytokine flow-cytometry assays in peripheral blood lymphocytes assaying reactivity against the four pooled WT1 antigens comprising GPS.
- Safety profile of GPS in combination with pembrolizumab similar to pembrolizumab alone, with the only addition of low-grade, rapidly resolving local reactions at the GPS injection site, consistent with observation from other GPS clinical studies.
For full trial information, please visit ClinicalTrials.gov
Malignant Pleural Mesothelioma (MPM)
Randomized, double-blind, placebo-controlled Phase 2 study of GPS monotherapy in a total of 41 MPM patients enrolled at MSKCC and M.D. Anderson Cancer Center
Randomized, double-blind, placebo-controlled Phase 2 study of GPS monotherapy in a total of 41 MPM patients enrolled at MSKCC and M.D. Anderson Cancer Center
- Median overall survival (OS) was 22.8 months in the GPS arm vs. 18.3 months in the control arm (HR: 0.79), with a median follow-up of 17.2 months (Zauderer M et al, Clin Cancer Res. 2017;23:7483-9)
- Datasets from both analyses: GPS induced CD8+ and CD4+ T cell activation.
- Well-tolerated safety profile in MPM patients.
Malignant Pleural Mesothelioma (MPM)
Phase 1 investigator-sponsored study of GPS in combination with nivolumab (Opdivo®) in advanced MPM patients (NCT04040231)
Phase 1 investigator-sponsored study of GPS in combination with nivolumab (Opdivo®) in advanced MPM patients (NCT04040231)
- Patients with CPS of less than 1:
- Median OS: 3.2 months.
- Median PFS: 1.9 months.
- Patients with CPS of 1 or more:
- Median OS: 18.4 months.
- Median PFS: 3.8 months.
- Investigator-sponsored clinical trial (IST) of GPS in combination anti-PD-1 therapy, nivolumab (Opdivo®), in patients with MPM who were either refractory to or relapsed after at least one line of standard care therapy.
- Conducted to determine if administration of GPS in combination with nivolumab has potential to demonstrate antitumor immune responses and meaningful clinical activity in the presence of macroscopic disease in MPM patients.
- Study also investigated tolerability of the combination, evaluated immunogenicity of the two agents together, by CD4+ and CD8+ T-lymphocytes (both peripherally and at tumor site), and gauged degree of clinical benefit by assessment of overall response rate (ORR) with combination in comparison to that reported historically with nivolumab alone in comparable patient population.
- Mean overall survival (OS): 70.3 weeks (17.6 months) in patients who received combination therapy (9/10 patients) and 54.1 weeks (13.5 months for all 10 patients (9 patients with combination therapy and 1 patient with GPS only).
- Median OS for Stage IV patients: 62.3 weeks (15.6 months).
- Median OS among patients who did not have immune response to GPS: 9
months. - Median OS for patients who had immune response to GPS: 27.8 months.
- Median progression-free survival (PFS): 11.9 weeks for all patients.
- 30% disease control rate (DCR) (the sum of overall response rate [ORR] and rate of stable disease) with 3 patients achieving stable disease per RECIST criteria with tumor volume decrease of up to 17%.
- 7 out of 10 patients had treatment related to toxicities.
- 6 patients had nivolumab related toxicities.
- Grade 3 and higher toxicities were observed in 3 patients. None were related to GPS. GPS related toxicities were observed in 3 patients – all were Grade 1 and included Grade 1 skin induration at the site of injection/injection site reaction and/or fatigue in 2 patients, and Grade 1 dizziness (1 patient) and non-cardiac chest pain (1 patient).
For full trial information, please visit ClinicalTrials.gov
Multiple Myeloma (MM)
Open-label Phase 2 study of GPS monotherapy in high-risk multiple myeloma (MM) patients (NCT01827137)
Open-label Phase 2 study of GPS monotherapy in high-risk multiple myeloma (MM) patients (NCT01827137)
- 88% actuarial overall survival (OS) at 18 months in 18 evaluable patients (median follow-up: 18 months for survivors).
- All patients had evidence of measurable residual disease (MRD) after autologous stem cell transplant (ASCT) and 15 had high-risk cytogenetics at diagnosis. Combined, these characteristics typically result in low PFS rates that do not exceed 12-14 months following ASCT, even while on maintenance therapy with immune-mediated inflammatory diseases or proteasome inhibitors.
- Median PFS: 23.6 months.
- Median OS had not been reached.
- Safety profile was devoid of grade 3/4/5 treatment – related adverse events.
For full trial information, please visit ClinicalTrials.gov
SLS009 Completed Clinical Trials:
Relapsed and/or Refractory Hematologic Malignancies
Phase 1 clinical trial of SLS009 in China and United States (NCT04588922)
Phase 1 clinical trial of SLS009 in China and United States (NCT04588922)
- Interim analysis of 72 patients in AML cohort (n=31) and lymphoma cohort (n=41), who were high-risk, advanced, heavily pretreated and resistant to multiple prior therapies.
- 94% of patients (29 out of 31 in AML cohort and 39 out of 41 in lymphoma cohort) are alive as of May 2023, with 1 patient alive more than 18 months following beginning of treatment.
- 77% bone marrow blast elimination in the highest dose.
- Anti-tumor activity and clinical responses across groups and dose levels observed.
- AML cohort:
- 9 mg twice-a-week (BIW) regimen: 50.0% bone marrow blast (BMB) reduction.
- 15 mg BIW: 53.8% BMB reduction.
- 30 mg once a week (QW) regimen: 57.1% BMB reduction.
- 45 mg QW 61.3% BMB reduction.
- 60 mg QW: 77.3% BMB reduction.
- Durable complete remission (CR) with no minimal residual disease (MRD) in 1 patient with AML who failed prior venetoclax plus azacitidine (aza/ven) therapy. Duration of response was 8 months.
- No dose limiting toxicities; no higher grade non-hematologic toxicities of any kind; some hematologic toxicities difficult to determine in patients with hematologic cancers, but short in duration and reversible.
- Pharmacokinetic (PK) data: achieved desired 24 hours > IC90 peripheral blood concentrations after first infusion, with IC90 concentrations resulting in up to 97% cancer cell killed.
- Pharmacodynamic (PD) Data: achieved desired levels of MCL1 and MYC suppression in peripheral blood with decrease in MCL1 or MYC observed in 97% (66 out of 68) of analyzed patients. Trend of proportionally increased maximum inhibition of MCL1 and MYC observed among higher doses (22.5 mg to 60 mg) in both AML and lymphoma patients, which is more prominent in QW regimen compared to BIW regimen. QW regimen was able to induce longer sustained inhibition (at least 6 hours) of MCL1 and MYC than BIW treatment, allowing longer period for CDK9 inhibition to induce cancer cell apoptosis.
- Lymphoma cohort:
- Response observed across dose levels.
- 14.7% clinical response rate overall.
- 35.3% overall disease control rate.
- 36.4% clinical response rate in PTCL patients.
- Decrease in MCL1 and/or MYC biomarkers observed in 100% of patients in a dose-dependent manner in once per week administration regimen.
- Recommended phase 2 dose for lymphoma patients established at 100 mg, once per week.
- No off-target safety issues at any dose level.
For full trial information, please visit ClinicalTrials.gov
Expanded Access Policy
SELLAS Life Sciences is committed to developing promising new therapies to address the unmet medical needs of patients suffering from a broad range of cancers. Consistent with SELLAS’ mission to bring innovative therapies to patients diagnosed with cancer, our goal is to provide access to our therapeutics at the appropriate time and in a manner that is most beneficial to the relevant patient population. We are focused on enrolling patients in our ongoing clinical trials necessary to gain regulatory approvals and to make our therapies available broadly to patients as quickly as possible – this remains the primary way for patients to access our investigational drugs. We are privileged to collaborate with clinical investigators, study teams, and patients, who all participate in our clinical studies to develop new, safe, and effective therapies. We encourage all patients and physicians to visit the pipeline page of our website to learn more about SELLAS’ ongoing clinical trials and enrollment. Further information surrounding our clinical trials can also be found by searching ‘SELLAS’ or the name of the investigational drug on ClinicalTrials.gov.
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We recognize that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in clinical trials, and thus, wish to access our investigational drugs. In these situations, SELLAS will consider requests from qualified physicians to use our investigational drugs, outside of the clinical trial setting i.e., in an Expanded Access Program (EAP), when certain conditions are met. These conditions are as follows:
- The patient to be treated has a serious or immediately life-threatening illness and there is no satisfactory or comparable alternative therapy.
- The patient is not eligible for, or cannot access, any ongoing clinical trials.
- The potential benefit of the investigational drug to the patient outweighs the potential risk. This should be evaluated by the patient’s physician and discussed in detail with the patient.
- Expanded Access requests for our investigational drugs must come from a patient’s treating physician who agrees to comply with all applicable legal and regulatory requirements in relation to the request and any requirements in terms of medical criteria (e.g., clinical monitoring of the drug use), safety reporting or other data provision which SELLAS may require.
- There is an adequate supply of the investigational drug, over and above what is required for the ongoing clinical trials and other patients on active treatment.
- Providing the investigational drug will not interfere with clinical trials that could support a medical product’s development or marketing approval.
SELLAS is committed to providing a fair and equitable evaluation of all EA requests but will review requests on a case-by-case basis. All requests must be submitted by the patient’s treating physician to . SELLAS may require more detailed information in order to fully evaluate a request. The fact that our investigational drug is made available to one patient does not guarantee it will be made available to future patients. We do not guarantee that all requests for access will be granted, even when eligibility criteria are met.in order to fully evaluate a request. The fact that our investigational drug is made available to one patient does not guarantee it will be made available to future patients. We do not guarantee that all requests for access will be granted, even when eligibility criteria are met. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within five (5) business days after receipt. You can find further contact details on the contact page of our website.
At this time, we are only accepting Expanded Access requests for investigational galinpepimut-S (GPS).
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