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Monoclonal Antibodies

Ociperlimab + Tislelizumab for Solid Cancers

Phase 1
Waitlist Available
Led By Tarek Meniawy, MD
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
Patients with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for which treatment is not available, not tolerated or refused
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1.5 years
Awards & highlights

Study Summary

This trial is testing a new combination cancer treatment to see how safe and effective it is. They will also be looking at what dose is tolerated or maximum administered dose.

Who is the study for?
This trial is for adults with advanced solid tumors who've had standard treatments or can't tolerate them. They should be relatively active (ECOG ≤1), have at least one measurable tumor, and good organ function. It's not for those with severe infections, autoimmune diseases that might flare up, brain metastasis, prior treatment for recurrent/metastatic disease in certain cancers, or previous therapy targeting immune checkpoints.Check my eligibility
What is being tested?
The study tests Ociperlimab combined with Tislelizumab to find the safest dose and see how well it works against solid tumors. Phase 1 focuses on safety and finding the right dose; Phase 1b looks at how effectively the drugs shrink tumors using a specific measurement criteria (RECIST v1.1).See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation of organs, infusion-related reactions like fever or chills, fatigue from treatment burden on the body, digestive issues due to drug impact on gut health, blood disorders affecting cell counts or clotting ability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I have an advanced cancer that can't be removed by surgery and have tried or can't undergo standard treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 Dose Escalation - Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
Phase 1 Dose Escalation - Number of participants experiencing Serious Adverse Events (SAEs)
Phase 1 Dose Escalation - Recommended Phase Ib dose (RP2D) of ociperlimab in combination with tislelizumab
+1 more
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Immunogenicity as assessed by the presence of anti-drug antibodies
+1 more

Trial Design

11Treatment groups
Experimental Treatment
Group I: Phase1b Cohort 9Experimental Treatment6 Interventions
Patients with metastatic G/GEJ carcinoma will be treated with ociperlimab + tislelizumab + [oxalipatin + capecitabine] or [cisplatin + 5-fluorouracil] Q3W for 6 cycles followed by ociperlamib+tislelizumab + capecitabine Q3W
Group II: Phase1b Cohort 8Experimental Treatment2 Interventions
Patients with recurrent or metastatic HNSCC (PD-L1 positive, vCPS≥ 1%) will be treated with ociperlimab + tislelizumab Q3W
Group III: Phase1b Cohort 7Experimental Treatment5 Interventions
Patients with metastatic EAC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil or paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W
Group IV: Phase1b Cohort 6Experimental Treatment5 Interventions
Patients with metastatic ESCC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil /paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W
Group V: Phase 1b Cohort10Experimental Treatment2 Interventions
Patients with metastatic NSCLC (PD-L1 positive, [TC] ≥ 1%) will be treated with tislelizumab in combination with ociperlimab 450mg, 900mg or 1800mg Q3W.
Group VI: Phase 1b Cohort 5Experimental Treatment2 Interventions
Checkpoint inhibitor (CPI)-experienced NSCLC patients will be treated with ociperlimab plus tislelizumab
Group VII: Phase 1b Cohort 4Experimental Treatment5 Interventions
Patients with extensive stage SCLC will be treated with ociperlimab + tislelizumab + etoposide + Cis/Carbo Q3W for up to 6 to 8 cycles followed by ociperlamib+tislelizumab Q3W
Group VIII: Phase 1b Cohort 3Experimental Treatment2 Interventions
Participants with metastatic NSCLC (PD-L1 positive, [TC] ≥ 1%) will be treated with ociperlimab + tislelizumab
Group IX: Phase 1b Cohort 2Experimental Treatment5 Interventions
Participants with metastatic squamous NSCLC will receive ociperlimab + tislelizumab + pemetrexed + Cis/Carbo Q3W for 4 to 6 cycles (21 days each) followed by ociperlamib+tislelizumab Q3W)
Group X: Phase 1b Cohort 1Experimental Treatment5 Interventions
Participants with metastatic squamous NSCLC will receive ociperlamib + tislelizumab + paclitaxel/nab-paclitaxel + Carbo once every 3 weeks (Q3W) for 4 to 6 cycles (21 days each) followed by ociperlimab + tislelizumab Q3W)
Group XI: Phase 1Experimental Treatment2 Interventions
Cycle 1 (28 Days): A flat dose of ociperlimab as a single agent on Day 1. In the first cycle, 200 mg tislelizumab will be administered on Day 8. If ociperlamib is tolerated in Cycle 1, participants will receive tislelizumab + ociperlimab sequentially on Day 29 and every 21 days for up to 8 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Ociperlimab
2021
Completed Phase 2
~530
Oxaliplatin
2011
Completed Phase 4
~2560
Pemetrexed
2014
Completed Phase 3
~5250
Nab paclitaxel
2014
Completed Phase 2
~140
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Etoposide
2010
Completed Phase 3
~2440
Tislelizumab
2018
Completed Phase 3
~4260
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
177 Previous Clinical Trials
28,611 Total Patients Enrolled
Tarek Meniawy, MDPrincipal InvestigatorLinear Clinical Research
Study DirectorStudy DirectorBeiGene
1,221 Previous Clinical Trials
499,525 Total Patients Enrolled

Media Library

Ociperlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04047862 — Phase 1
Solid Tumors Research Study Groups: Phase 1b Cohort 2, Phase 1b Cohort 4, Phase 1b Cohort 3, Phase1b Cohort 7, Phase 1b Cohort 5, Phase 1b Cohort10, Phase1b Cohort 9, Phase 1, Phase1b Cohort 6, Phase 1b Cohort 1, Phase1b Cohort 8
Solid Tumors Clinical Trial 2023: Ociperlimab Highlights & Side Effects. Trial Name: NCT04047862 — Phase 1
Ociperlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04047862 — Phase 1
~15 spots leftby Aug 2024
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