SAR444881 + Standard Therapies for Advanced Cancer
Recruiting in Palo Alto (17 mi)
+43 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Biond Biologics
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This trial tests a new drug, SAR444881, alone and with other treatments in advanced cancer patients who haven't responded to other therapies. The goal is to find the best dose and combination to treat these patients effectively.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have taken cytotoxic or non-cytotoxic anti-cancer agents within 4 weeks before the trial, and you must not use other investigational drugs or have had a live attenuated vaccine within 28 days before the trial.
What data supports the idea that SAR444881 + Standard Therapies for Advanced Cancer is an effective treatment?
The available research does not provide specific data on the effectiveness of SAR444881 combined with standard therapies for advanced cancer. The studies mentioned focus on other drugs and treatments for advanced cancer, such as binimetinib, buparlisib, alpelisib, tamoxifen, goserelin, SB-743921, sunitinib, and capecitabine. Without direct evidence or data on SAR444881, we cannot conclude its effectiveness compared to these other treatments.12345
What safety data is available for SAR444881 and related treatments in advanced cancer?
The provided research does not contain specific safety data for SAR444881 or its related treatments like BND-22, Cetuximab, ABP-494, or Pembrolizumab. The studies focus on other drugs such as SB-743921, sorafenib, SU11248, and SAR125844, assessing their safety, pharmacokinetics, and antitumor activity in various cancers. For SAR444881 and related treatments, further specific studies would be needed to determine their safety profiles.36789
Research Team
CS
Clinical Sciences & Operations
Principal Investigator
Sanofi
Eligibility Criteria
This trial is for adults with advanced solid tumors that can't be removed by surgery or have spread, and who haven't responded to standard treatments. They must be physically able to perform daily activities (ECOG 0-1) and have proper organ function. Specific cancers like lung, breast, head and neck among others are included depending on the study part.Inclusion Criteria
Histologic confirmation of malignancy
Measurable disease per RECIST v1.1
My cancer is one of the following: head and neck, stomach, or non-small cell lung cancer.
See 4 more
Exclusion Criteria
I am on steroids or other drugs that suppress my immune system.
I have had a solid organ or bone marrow transplant.
I have not received a live vaccine in the last 28 days.
See 11 more
Treatment Details
Interventions
- BND-22 (Monoclonal Antibodies)
- Cetuximab (Monoclonal Antibodies)
- Pembrolizumab (Monoclonal Antibodies)
Trial OverviewThe trial tests SAR444881 alone and in combinations with pembrolizumab, cetuximab, carboplatin, or pemetrexed. It has two parts: dose escalation to find safe levels of SAR444881 (alone/with drugs), then dose optimization/expansion where effective doses are given more widely. Part of the second phase involves random selection for treatment groups.
Participant Groups
5Treatment groups
Experimental Treatment
Group I: SAR444881 in Combination with Pembrolizumab Dose Escalation (Sub-Part 1B)Experimental Treatment2 Interventions
Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. SAR444881 and pembrolizumab will be administered intravenously (IV), every 3 weeks (Q3W).
Group II: SAR444881 in Combination with Cetuximab Dose Escalation (Sub-Part 1C)Experimental Treatment2 Interventions
Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. SAR444881 and cetuximab will be administered intravenously (IV), every 2 weeks (Q2W).
Group III: SAR444881 Dose Optimization (Sub-Part 2A)Experimental Treatment5 Interventions
SAR444881 Dose Optimization in combination with pembrolizumab/carboplatin/pemetrexed, pembrolizumab, or cetuximab. The indication for the combination cohorts will be non-squamous non-small cell lung cancer (NSCLC), gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), colorectal carcinoma (CRC) any RAS. Enrollment will start after the recommended dose(s) of SAR444881 have been determined based on data from Sub-Parts 1A, 1B, and 1C.
Group IV: SAR444881 Dose Expansion (Sub-Part 2B)Experimental Treatment1 Intervention
The indication for this monotherapy cohort is cholangiocarcinoma. Enrollment will be opened based on emerging data from the dose-escalation phase and combination optimization data.
Group V: SAR444881 Dose Escalation (Sub-Part 1A)Experimental Treatment1 Intervention
Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. SAR444881 will be administered intravenously (IV), every 2 weeks (Q2W).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clermont Oncology Center Site Number : 8400005Clermont, FL
Mid Florida Cancer Center Site Number : 8400006Orange City, FL
Cancer Treatment Centers of America at Southeastern Regional Medical Center Site Number : 8400009Newnan, GA
Cancer Treatment Centers of America at Midwestern Regional Medical Center Site Number : 8400010Zion, IL
More Trial Locations
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Who Is Running the Clinical Trial?
Biond Biologics
Lead Sponsor
Trials
2
Patients Recruited
740+
Sanofi
Lead Sponsor
Trials
2246
Patients Recruited
4,085,000+
Findings from Research
In a phase Ib study involving 89 patients with advanced solid tumors, the combination of binimetinib (a MEK inhibitor) and buparlisib (a PI3K inhibitor) showed some efficacy, particularly in RAS/BRAF-mutant ovarian cancer, where 12% of patients achieved a partial response.
However, the treatment was associated with significant toxicities, leading to a lower than expected dose intensity, suggesting that alternative dosing strategies, like pulsatile dosing, may be necessary to improve safety and tolerability in future trials.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase Ib Study of Combination Therapy with MEK Inhibitor Binimetinib and Phosphatidylinositol 3-Kinase Inhibitor Buparlisib in Patients with Advanced Solid Tumors with RAS/RAF Alterations.Bardia, A., Gounder, M., Rodon, J., et al.[2023]
The study established the recommended phase 2 doses (RP2D) for alpelisib (350 mg) and buparlisib (100 mg) when combined with tamoxifen and goserelin in premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer, showing that both combinations were well-tolerated.
Patients treated with alpelisib experienced a longer progression-free survival of 25.2 months compared to 20.6 months for those on buparlisib, suggesting that alpelisib may be a more effective option for this patient group.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A Phase Ib Study of Alpelisib or Buparlisib Combined with Tamoxifen Plus Goserelin in Premenopausal Women with HR-Positive HER2-Negative Advanced Breast Cancer.Lu, YS., Lee, KS., Chao, TY., et al.[2021]
The maximum-tolerated dose (MTD) of SB-743921 was established at 4 mg/m², with neutropenia being the most common dose-limiting toxicity observed in a study involving 44 patients with advanced solid tumors or relapsed/refractory lymphoma.
One patient experienced a durable objective response lasting 11 months, and 6 patients had stable disease for over four treatment cycles, indicating promising efficacy and a favorable safety profile for further development of SB-743921.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A first in human study of SB-743921, a kinesin spindle protein inhibitor, to determine pharmacokinetics, biologic effects and establish a recommended phase II dose.Holen, KD., Belani, CP., Wilding, G., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Targeted therapy in cancer.Tsimberidou, AM.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A phase I study of sunitinib plus capecitabine in patients with advanced solid tumors.Sweeney, CJ., Chiorean, EG., Verschraegen, CF., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase II study of sorafenib in patients with metastatic or recurrent sarcomas.Maki, RG., D'Adamo, DR., Keohan, ML., et al.[2022]
SAR125844, a selective c-Met kinase inhibitor, was found to have acceptable tolerability in a phase I trial with 38 Asian patients, including those with gastric cancer and MET amplification, with the maximum tolerated dose established at 570 mg/m2.
While no objective responses were observed in the initial dose-escalation cohort, modest antitumor activity was noted in the dose-expansion cohort, particularly in patients with MET-amplified gastric cancer, where two patients achieved partial responses.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase I dose-escalation study of the c-Met tyrosine kinase inhibitor SAR125844 in Asian patients with advanced solid tumors, including patients with MET-amplified gastric cancer.Shitara, K., Kim, TM., Yokota, T., et al.[2023]
The combination of sorafenib and ifosfamide was found to be safe at a recommended dose of sorafenib 400 mg twice daily and ifosfamide 6 g/m², with some dose-limiting toxicities observed, including severe fatigue and encephalopathy.
Out of 12 patients with advanced sarcoma, 8 achieved stable disease for over 12 weeks, indicating limited preliminary antitumor activity, which supports further investigation in a phase II study.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase I trial of sorafenib in combination with ifosfamide in patients with advanced sarcoma: a Spanish group for research on sarcomas (GEIS) study.Martín-Liberal, J., López-Pousa, A., Broto, JM., et al.[2021]
Sunitinib, an oral multitargeting tyrosine kinase inhibitor, was found to have manageable toxicity at a recommended dose of 50 mg/day, with common side effects including sore mouth, edema, and thrombocytopenia.
The drug demonstrated antitumor activity in various cancers, including renal cell carcinoma, with six objective responses observed, indicating its potential for further studies in treating advanced malignancies.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer.Faivre, S., Delbaldo, C., Vera, K., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
SARC009: Phase 2 study of dasatinib in patients with previously treated, high-grade, advanced sarcoma.Schuetze, SM., Wathen, JK., Lucas, DR., et al.[2022]
In a phase I trial involving 25 patients with solid tumors, SR233377 was found to have tolerable side effects, including mild neutropenia and nausea, but was limited by dose-dependent QTc prolongation, which can increase the risk of serious heart issues.
Despite the safety concerns, some patients experienced significant tumor growth inhibition lasting over 4 months, indicating potential efficacy of SR233377 against solid tumors, although further studies with different dosing schedules are needed.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase I/pharmacokinetic trial of the novel thioxanthone SR233377 (WIN33377) on a 5-day schedule.Stevenson, JP., DeMaria, D., Reilly, D., et al.[2007]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase I study of the combination of crizotinib (as a MET inhibitor) and dasatinib (as a c-SRC inhibitor) in patients with advanced cancer.Kato, S., Jardim, DL., Johnson, FM., et al.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Dasatinib plus capecitabine for advanced breast cancer: safety and efficacy in phase I study CA180004.Somlo, G., Atzori, F., Strauss, LC., et al.[2022]
References
Phase Ib Study of Combination Therapy with MEK Inhibitor Binimetinib and Phosphatidylinositol 3-Kinase Inhibitor Buparlisib in Patients with Advanced Solid Tumors with RAS/RAF Alterations. [2023]
A Phase Ib Study of Alpelisib or Buparlisib Combined with Tamoxifen Plus Goserelin in Premenopausal Women with HR-Positive HER2-Negative Advanced Breast Cancer. [2021]
A first in human study of SB-743921, a kinesin spindle protein inhibitor, to determine pharmacokinetics, biologic effects and establish a recommended phase II dose. [2021]
Targeted therapy in cancer. [2018]
A phase I study of sunitinib plus capecitabine in patients with advanced solid tumors. [2021]
Phase II study of sorafenib in patients with metastatic or recurrent sarcomas. [2022]
Phase I dose-escalation study of the c-Met tyrosine kinase inhibitor SAR125844 in Asian patients with advanced solid tumors, including patients with MET-amplified gastric cancer. [2023]
Phase I trial of sorafenib in combination with ifosfamide in patients with advanced sarcoma: a Spanish group for research on sarcomas (GEIS) study. [2021]
Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. [2022]
SARC009: Phase 2 study of dasatinib in patients with previously treated, high-grade, advanced sarcoma. [2022]
Phase I/pharmacokinetic trial of the novel thioxanthone SR233377 (WIN33377) on a 5-day schedule. [2007]
Phase I study of the combination of crizotinib (as a MET inhibitor) and dasatinib (as a c-SRC inhibitor) in patients with advanced cancer. [2020]
Dasatinib plus capecitabine for advanced breast cancer: safety and efficacy in phase I study CA180004. [2022]