OncoMatch/Clinical Trials/NCT06612632
Immunotherapy Rechallenge in Patients with Solid Tumors in Clinical Trials
Is NCT06612632 recruiting? Yes, currently enrolling (Sep 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