Not Yet RecruitingPhase 1/2

IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors

China52 participantsStarted 2026-05-15

Plain-language summary

Phase 1/2 Study for IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent must be obtained before any study procedure is performed.
✓. Men or women 18 years of age or older.
✓. Histologically or cytologically confirmed advanced or recurrent malignant solid tumors that are metastatic or unresectable. (Subjects must submit tumor tissue sections from within the past 5 years for CCR8 expression testing. For subjects without paraffin-embedded tissues, a fine-needle aspiration biopsy may be performed. Subjects who cannot provide tumor tissue sections or undergo biopsy are only eligible for inclusion during the dose escalation phase. During the dose expansion phase, CCR8 positivity must be known or tumor tissue sections must be provided with confirmed CCR8 expression.)
✓. Subjects must have failed or been intolerant to standard antitumor therapy, or lack a standard treatment regimen, or be deemed by the investigator as currently unsuitable for standard therapy.
✓. According to the RECIST 1.1 criteria, there is at least one measurable lesion.
✓. Life expectancy ≥ 3 months.
✓. Subjects must be able to swallow the oral investigational drug.
✓. The ECOG performance status score is 0 or 1.

Exclusion criteria

✕. Primary malignant tumors of the central nervous system or malignant tumors associated with human immunodeficiency virus (HIV) .
✕. Previous use of CCR8-targeted therapy.
✕. Received the following treatment within the specified time frame:
✕. Planned major surgery within 4 weeks prior to the first dose administration (excluding minor procedures such as vascular access placement, gastrointestinal/biliary stent placement, or biopsy);
✕. Immunotherapy or biological therapy administered within 28 days prior to the initial administration;
✕. Chemotherapy \<21 days prior to the first dose, or mitomycin or nitrosoureas \< 42 days prior, or oral fluoropyrimidines \< 14 days prior;
✕. Targeted small-molecule therapy or traditional Chinese medicine with antitumor indications administered within 14 days prior to the initial dose;
✕. Hormone therapy or other adjuvant therapies are not permitted if initiated within 14 days prior to the first dose. Exceptions: anti-estrogen therapy, bisphosphonates, RANKL monoclonal antibodies, somatostatin analogs, and leuprorelin are permitted if initiated ≥ 14 days prior to the first dose.

What they're measuring

Incidence of Dose-Limiting Toxicity (DLT)

Timeframe: Up to 21 days after first dose (Cycle 1): To determine the DLT according to NCI CTCAE v6.0, and define the Maximum Tolerated Dose (MTD) and RP2D of IPG7236 in combination with toripalimab

Percentage of patients with adverse events

Timeframe: From first dose to 90 days after last dose or initiation of new anti-cancer therapy, whichever comes first

Trial details

NCT IDNCT07508761

SponsorNanjing Immunophage Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

jian fei wang, CSO

+86-21-34782827 jfwang@immunophage.com.cn

View on ClinicalTrials.gov More Advanced Solid Tumor trials