OncoMatch/Clinical Trials/NCT06612632
Immunotherapy Rechallenge in Patients with Solid Tumors in Clinical Trials
Official title: A Umbrella Study to Evaluate the Safety and Preliminary Efficacy of Combined or Sequential Immunotherapy in Patients with Advanced Solid Tumors Progressing on Clinical Trial Drugs
Is NCT06612632 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including research drug in combination with Toripalimab and Toripalimab for cancer.
Treatment: research drug in combination with Toripalimab · Toripalimab — This study plans to include approximately 60-100 patients with advanced solid tumors who have progressed on clinical trial drugs. It will use an open-label, single-arm, multi-cohort umbrella design. In the first phase, patients who have progressed during treatment with novel tumor immunotherapy drugs will initially be targeted, combining or sequencing with PD-1 monoclonal antibody therapy. The inclusion criteria for frontline clinical trials are as follows: priority will be given to phase I clinical trials of novel immunotherapeutics as monotherapy, such as tumor vaccines, NK cell therapy, and new immune checkpoint inhibitors. Based on preliminary data, these have shown synergistic effects with PD-1/L1 monoclonal antibodies. In principle, the same investigational drug will only be used in either a combination or sequencing cohort. Subsequently, the study will expand to include patients who have progressed on other clinical trial treatments, combining or sequencing with other immune mechanism drugs.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic anti-tumor treatment (clinical trial of a new drug) — first-line
Previous first-line treatment involved a clinical trial of a new drug, with disease progression, and deemed by the investigator to no longer benefit from it
Cannot have received: immunotherapy
Exception: if previous exposure resulted in severe immune-related adverse events, as assessed by the investigator, making re-administration inappropriate
Previous exposure to immunotherapy (standard treatment or clinical trials) resulted in severe immune-related adverse events, as assessed by the investigator, making the re-administration of immunotherapy inappropriate
Cannot have received: immunotherapy
Exception: if previously experienced hyperprogression during immune therapy (tumor progression time <2 months, tumor burden increased >50% from baseline, or tumor growth rate post-immunotherapy >2x previous rate)
Previously experienced hyperprogression during immune therapy (conventional treatment or clinical trials)... Criteria include: (1) Tumor progression time less than two months during immunotherapy (2) Tumor burden increased by over 50% compared to baseline (3) Tumor growth rate post-immunotherapy exceeds twice the previous rate
Cannot have received: other anti-tumor therapy
Exception: between the last front-line therapy and the first dose of the study drug
Received other anti-tumor therapy between the last front-line therapy and the first dose of the study drug
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06612632 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapy, immunotherapy, other anti-tumor therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify