IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors

NCT07508761 | Not Yet Recruiting Phase 1

• 1 other identifier: IPG7236-C003
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicity (DLT)

  Dose-Limiting Toxicity (DLT) is treatment-related adverse events (excluding disease progression/external causes) per NCI CTCAE v6.0, occurring within Cycle 1 Day 1-21,1) Unexplained death; 2) Hematological: Grade 4 neutropenia \>7d; Grade ≥3 febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 with clinical bleeding; Grade 4 anemia; 3) Non-hematological: Grade ≥3 (exceptions: Grade 3 nausea/vomiting/diarrhea \<3d with antiemetics; Grade 3 fatigue \<1w; pancreatitis-unrelated Grade ≥3 amylase/lipase; Grade ≥3 electrolyte disturbance resolving within 72h without complications; asymptomatic isolated lab abnormalities); Hepatotoxicity: Hy's Law (ALT/AST \>3×ULN + total bilirubin \>2×ULN + ALP \<2×ULN); AST/ALT \>8×ULN (or \>8×baseline for liver metastasis); AST/ALT \>5×ULN (or \>5×baseline for liver metastasis) ≥14d; Other Grade 4 non-hematological toxicity; 4) Toxicity requiring permanent study drug discontinuation or \<75% planned administration. Infusion-related reactions are not DLT;

  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

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

Secondary Outcomes (10)

• Objective Response Rate (ORR) per iRECIST v1.1

  From first dose to disease progression or death (up to 24 months)

• Disease Control Rate (DCR) per iRECIST v1.1

  From first dose to disease progression or death (up to 24 months)

• Duration of Response (DoR) per iRECIST v1.1

  From first documentation of objective response (CR or PR) to first documentation of progressive disease (PD) or death (up to 24 months)

• Progression-Free Survival (PFS) per iRECIST v1.1

  From first dose to disease progression or death (up to 24 months)

• Overall Survival (OS) per iRECIST v1.1

  From first dose to death due to any cause (up to 24 months)

Study Arms (3)

Part A（Cohort 1） ：IPG7236 500mg & Toripalimab

EXPERIMENTAL

3-6 subjects in this cohort will receive IPG7236 500 mg BID and Toripalimab Injection 240 mg， Dose-escalation cohort with 3+3 design; DLT assessment period is 21 days.

Drug: IPG7236; Drug: Toripalimab Injection

Part A（Cohort 2）：IPG7236 800mg& Toripalimab

EXPERIMENTAL

3-6 subjects in this cohort will receive IPG7236 800 mg BID and Toripalimab Injection 240 mg，Dose-escalation cohort with 3+3 design; enrolled sequentially after Cohort 1; DLT assessment period is 21 days.

Drug: IPG7236; Drug: Toripalimab Injection

Part B：IPG7236 RP2D & Toripalimab

EXPERIMENTAL

40 subjects in this cohort will receive IPG7236 at the RP2D BID and Toripalimab Injection 240 mg

Drug: IPG7236; Drug: Toripalimab Injection

Interventions

IPG7236 DRUG

IPG7236: Part A: 500 mg BID or 800 mg BID, the dose in Part B is the RP2D confirmed in Part A, Oral (fasting: 1 hour before meal or 2 hours after meal, every 12±2 hours), Continuous daily administration, 21-day treatment cycle,Until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons for withdrawal

Part A（Cohort 1） ：IPG7236 500mg & Toripalimab; Part A（Cohort 2）：IPG7236 800mg& Toripalimab; Part B：IPG7236 RP2D & Toripalimab

Toripalimab Injection DRUG

Toripalimab Injection: 240 mg , Q3W, 21-day treatment cycle, the first infusion lasts at least 60 minutes; if well tolerated, subsequent infusions can be shortened to 30 minutes.

Part A（Cohort 1） ：IPG7236 500mg & Toripalimab; Part A（Cohort 2）：IPG7236 800mg& Toripalimab; Part B：IPG7236 RP2D & Toripalimab

Eligibility Criteria

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

You may qualify if:

• Written informed consent must be obtained before any study procedure is performed.
• Men or women 18 years of age or older.
• 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.
• Sufficient hematologic and organ function, with the following laboratory test values:
• Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L; platelet count ≥ 75×10⁹/L; Hemoglobin ≥ 9 g/dL; lymphocytes ≥ 0.8×10⁹/L;
• Renal: Creatinine clearance calculated by the Cockcroft-Gault method ≥ 50 mL/min or serum creatinine ≤ 1.5× upper limit of normal (ULN);
• Hepatic: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3×ULN, or ≤ 5×ULN for subjects with liver metastases; total bilirubin ≤ 1.5×ULN, or ≤ 3×ULN for subjects with Gilbert syndrome or genetically equivalent conditions;
• Coagulation: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5× upper limit of normal (ULN).
• Patients must be willing and able to comply with all scheduled visits, treatments, laboratory tests, and other study requirements.
• Male and female participants of reproductive potential who engage in heterosexual sexual behavior must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence,etc.) for at least 4 months during the trial period and after the last study drug administration (refer to Appendix 13.1 of the protocol)

You may not qualify if:

• 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.
• Radiotherapy administered within 28 days prior to the first dose, or palliative radiotherapy within 14 days prior. Exception: Palliative radiotherapy (e.g., for analgesia) may be performed during the study drug administration period, provided that it is not permitted during the DLT observation period, any previously induced adverse events from radiotherapy have been resolved to grade \<2, and the radiotherapy was not directed at the target lesion.
• Other investigational or treatments administered within 28 days prior to the first dose;
• Any previous allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation;
• In combination with other active malignancies (excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder cancer with no evidence of disease after potentially curative treatment; For other patients with previous malignant tumors who have survived without disease for more than 3 years, they are also (acceptable).
• Immune-related adverse events (irAEs) of grade ≥ 3 or those leading to treatment discontinuation during prior immunotherapy, or grade ≥ 2 immune-mediated myocarditis, or treatment discontinuation due to allergic or infusion-related reactions.
• Diagnosis of primary or acquired immunodeficiency, or receipt of systemic glucocorticoids or any other form of immunosuppressive therapy within 7 days prior to the first dose. Exceptions: intraocular, intranasal, intra-articular, inhaled, or systemic glucocorticoids (prednisone dose ≤ 10 mg/day or equivalent, or doses used for adrenal replacement therapy), as well as a single dose of immunosuppressive medication for contrast agent allergy prophylaxis (if no active autoimmune disease is present).
• History of autoimmune disease requiring systemic therapy or active autoimmune diseases (i.e., requiring glucocorticoids or immunosuppressive agents for disease control) within 2 years prior to study initiation are eligible, provided they do not require immunosuppressive therapy for conditions such as type 1 diabetes mellitus, vitiligo, psoriasis,hypothyroidism, or hyperthyroidism.

Sponsors & Collaborators

• Nanjing Immunophage Biotech Co., Ltd: lead

Study Sites (1)

Shanghai Gaobo Tumor Hospital

Shanghai, PuDongXinQu, 200120, China

Location

MeSH Terms

Interventions

toripalimab

Central Study Contacts

jian fei wang, CSO

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 2, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): July 30, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)