Phase 1/2 Study for IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors
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.
Primary malignant tumors of the central nervous system or malignant tumors associated with human immunodeficiency virus (HIV) .
Previous use of CCR8-targeted therapy.
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;
Single group
IPG7236
DrugIPG7236: 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
Toripalimab Injection
DrugToripalimab 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.
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;
Percentage of patients with adverse events
Objective Response Rate (ORR) per iRECIST v1.1
Objective Response Rate (ORR) is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) per iRECIST v1.1 criteria.
Disease Control Rate (DCR) per iRECIST v1.1
Disease Control Rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) per iRECIST v1.1 criteria.
Duration of Response (DoR) per iRECIST v1.1
Duration of Response (DoR) is defined as the time from first documentation of objective response (CR or PR) to first documentation of progressive disease (PD) or death due to any cause, per iRECIST v1.1 criteria.
Progression-Free Survival (PFS) per iRECIST v1.1
Progression-Free Survival (PFS) is defined as the time from first dose to first documentation of progressive disease (PD) per iRECIST v1.1 criteria or death due to any cause, whichever occurs first.
Click on the lead sponsor to view all of their trials.
