A Phase II Study of SHR-4602 as Montherapy or in Combination With Other Anti-tumor Therapies in Advanced Solid Tumors

Official title

An Open-label, Multi-center Phase II Study to Evaluate the Safety, Tolerablity, Pharmacokinetics, and Efficacy of SHR-4602 as Montherapy or in Combination With Other Anti-tumor Therapies in Sujbects With Advanced Solid Tumors

Overview

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4602 as montherapy or in combination with other anti-tumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-4602 for advanced solid tumors.

Interventions

• Drug SHR-4602
  SHR-4602

Primary outcome measures

• ORR by investigator assessment [Time frame: Up to approximately 5 years;]

Secondary outcome measures (5)

• DCR by investigator assessment, [Time frame: Up to approximately 5 years;]
• DoR by investigator assessment, [Time frame: Up to approximately 5 year]
• PFS by investigator assessment, [Time frame: Up to approximately 5 years;]
• OS [Time frame: Up to approximately 5 years;]
• Number of participants with adverse events (AEs), [Time frame: Up to approximately 5 years;]

Eligibility criteria

Inclusion criteria

• 18-80 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Stage I: subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, who have failed at least 1 line of standard treatment;
• Provide archived or fresh tumor tissue；HER2 expression is required for subjects in Stage I;
• At least one measurable lesion according to RECIST v1.1；
• Expected survival ≥12 weeks
• Good level of organ function；
• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, be non-lactating. Male subjects whose partners are women of childbearing age and female subjects who are fertile must agree to avoid sperm or egg donation during the treatment period until 8 months after the last dose of the investigational drug;
• Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements；

Exclusion criteria

• Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；
• Subjects with peripheral neuropathy；
• Have received anti-cancer treatment within 4 weeks prior the first dose of study treatment;
• Are participating in another clinical study or have received the last dose in a clinical study less than 4 weeks from the first dose;
• Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment;
• Have received treatment with strong CYP3A inducers or inhibitors, or P-gp inhibitors or inducers within 5 half-lives prior to the first dose;
• Toxicity and/or complications of previous antitumor therapy has not resolved to NCI-CTCAE level ≤1 or exclusion criteria；
• Have the following lung diseases or medical history: (1) known or suspected interstitial lung disease; (2) moderate to severe lung diseases that seriously affect lung function within the past 3 months; (3) any autoimmune, connective tissue, or inflammatory disease involving the lungs; (4) prior pneumonectomy; (5) Grade ≥ 3 interstitial lung disease during prior treatment with immune checkpoint inhibitors.
• Stage 2: ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors；
• Have any active, known or suspected autoimmune diseases;
• Moderate or severe ascites with clinical symptoms, uncontrolled or moderate or above pleural effusion and pericardial effusion；
• The presence of clinical cardiac symptoms or diseases that are not well controlled；
• Known hereditary or acquired hemorrhage and thrombophilia；
• Have untreated active hepatitis；
• Subjects who had a severe infection within 30 days prior to the first dose；
• Any other malignancy diagnosed within the previous 5 years；
• Patients with active tuberculosis infection within 1 year prior to enrollment, or with a history of active tuberculosis infection more than 1 year prior but without formal treatment；
• History of immune deficiency；
• Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study period；
• Known severe allergic reactions to any component of SHR-4602, or other monoclonal antibody/fusion protein drugs；
• Female subjects who are pregnant or plan to become pregnant during the study period；
• The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention；
• In the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

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

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT06704828 · SHR-4602-202

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗