Immunotherapy Rechallenge in Patients with Solid Tumors in Clinical Trials

NCT06612632 | Recruiting Phase 1

• 1 other identifier: NCC20231105
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

immunotherapy; rechallenge; clinical trail; solid tumor

Outcome Measures

Primary Outcomes (4)

• Number of Participants Experiencing AEs

  Number of participants with AE by CTCAE v5.0.

  5 years

• Number of Participants Experiencing TEAEs

  Number of Participants with TEAEs by CTCAE v5.0.

  5 years

• Number of Participants Experiencing TRAEs

  Number of Participants with TRAEs by CTCAE v5.0.

  5 years

• Number of Participants Experiencing SAEs

  Number of Participants with SAEs by CTCAE v5.0.

  5 years

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  5 years

• Disease Control Rate(DCR) Disease Control Rate(DCR) Disease Control Rate(DCR) Disease Control Rate(DCR)

  5 years

• Duration of Response (DOR)

  5 years

• Progression-Free Survival (PFS)

  5 years

• Overall Survival (OS)

  5 years

Study Arms (3)

Combination therapy

EXPERIMENTAL

Research drug in combination with Toripalimab

Drug: research drug in combination with Toripalimab

Sequential therapy

EXPERIMENTAL

Toripalimab

Drug: Toripalimab

RWS cohort

NO INTERVENTION

observation

Interventions

research drug in combination with Toripalimab DRUG

research drug in combination with Toripalimab

Combination therapy

Toripalimab DRUG

Toripalimab

Sequential therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent or metastatic solid tumors confirmed by histopathology that cannot be treated with curative local therapy
• Prior systemic anti-tumor treatment requirements: 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
• Suggested first dose administered within 12 weeks after the last treatment.
• According to the RECIST 1.1 criteria, there should be at least one measurable lesion or more
• ECOG PS 0-2 points
• expected survival ≥ 3 months
• as assessed by the investigator, major organ functions are good enough and can tolerate the experimental treatment regimen used in this study
• subjects can understand and comply with the study procedures, sign the informed consent form, and voluntarily participate in this study

You may not qualify if:

• 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.
• Previous adverse reactions to advanced solid tumors have persisted, and the investigator anticipates these might impact the safety evaluation of the investigational drug
• Previously experienced hyperprogression during immune therapy (conventional treatment or clinical trials), and the Other conditions deemed unsuitable for participation in this study by the investigator believes that no further benefit can be gained from this study. 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
• Central nervous system metastases or leptomeningeal metastases with clinical symptoms
• During the screening period, subjects are determined by the investigator to have severe or uncontrolled underlying diseases (such as hypertension, diabetes, cardiovascular diseases, pulmonary diseases, autoimmune diseases, etc.)
• Received other anti-tumor therapy between the last front-line therapy and the first dose of the study drug
• Other conditions deemed unsuitable for participation in this study by the investigator

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

toripalimab

Study Officials

• Ning Li

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawei Wu, Dr.

CONTACT

(+86)-010-87788165; wumingshi-117@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: An Umbrella Study

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: September 25, 2024
• Study Start: May 24, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)