A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour

Official title

An Phase II Clinical Study on the Safety, Tolerability and Efficacy of HRS-7058 in Combination With Antitumor Drugs in Subjects With Solid Tumors

Overview

This study is a multicentre, open phase II clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in combination with antitumor drugs in subjects with advanced malignant tumour. To evaluate the safety, tolerability and efficacy of HRS-7058 in combination with antitumor drugs.

Interventions

• Drug HRS-7058 + SHR-1316
  HRS-7058 + SHR-1316
• Drug HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy
  HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy
• Drug HRS-7058 + Cetuximab
  HRS-7058 + Cetuximab
• Drug HRS-7058 + SHR-1826
  HRS-7058 + SHR-1826
• Drug HRS-7058 + SHR-1826 + SHR-1316
  HRS-7058 + SHR-1826 + SHR-1316
• Drug HRS-7058 + SHR-A1202
  HRS-7058 + SHR-A1202
• Drug HRS-7058 + BP102
  HRS-7058 + BP102
• Drug HRS-7058 + SHR-9839
  HRS-7058 + SHR-9839
• Drug HRS-7058 +SHR-A2102 +SHR-1316
  HRS-7058 +SHR-A2102 +SHR-1316
• Drug HRS-7058 +SHR-9839(sc)+SHR-1316
  HRS-7058 +SHR-9839(sc)+SHR-1316

Primary outcome measures

• Dose-limiting toxicity (DLT) (Dose Escalation and Dose Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
• Safety endpoints: adverse events (AE) (Dose Escalation and Dose Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]]
• Phase II recommended dose (RP2D)(Dose Escalation and Dose Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]]
• Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Efficacy Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months]

Secondary outcome measures (10)

• Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
• Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
• Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
• Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
• Efficacy endpoints: overall survival (OS)(Dose Escalation and Dose Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
• Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Efficacy Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months]
• Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Efficacy Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months]
• Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Efficacy Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months]
• Efficacy endpoints: overall survival (OS) (Efficacy Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months]
• Safety endpoints: adverse events (AE)(Efficacy Expansion) [Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months]

Eligibility criteria

Inclusion criteria

• The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;
• 18 to 75 years old (including both ends), gender is not limited;
• Subjects with unresectable locally advanced or metastatic solid tumour confirmed by histopathology;
• Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1);
• ECOG Performance Status of 0 or 1;
• The expected survival time is more than 12 weeks;
• Be able to ingest drugs and be able to comply with trial and follow-up procedures;
• Adequate bone marrow and organ function;
• Female subjects of childbearing potential must undergo a serum pregnancy test within 7 days before the first administration of the study drug, and the result must be negative; and they must not be lactating. Female subjects of childbearing potential and male subjects whose partners are females of childbearing potential must agree to comply with contraceptive requirements from the time of signing the informed consent form until 5 months after the last administration of the study drug (for male subjects) or 8 months after the last administration of the study drug (for female subjects).

Exclusion criteria

• Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
• Antitumor therapy within 28 days prior to initial use of the investigational drug;
• The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1;
• With known or suspected interstitial pneumonia;
• With severe cardiovascular and cerebrovascular disease
• Had other malignancies within five years prior to first use of the investigational drug;
• Severe infection within 28 days prior to first use of the investigational drug;
• History of immune deficiency;
• Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
• The presence of uncontrolled pleural, abdominal or pericardial effusion;
• Had undergone major organ surgery within 28 days prior to the first use of the study drug;
• Women during pregnancy or lactation;
• Known allergies and contraindications to the investigational drug or any of its components;
• According to the judgment of the investigator, there are any other circumstances that may increase the risks of participating in the study, interfere with the study results, or make the subjects unsuitable for participating in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing
• Tianjin Cancer Hospital — Tianjin

Identifiers

NCT: NCT06915142 · HRS-7058-201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗