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

NCT06704828 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-4602-202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• ORR by investigator assessment

  ORR by investigator assessment was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), Up to approximately 5 years;

  Up to approximately 5 years;

Secondary Outcomes (5)

• DCR by investigator assessment,

  Up to approximately 5 years;

• DoR by investigator assessment,

  Up to approximately 5 year

• PFS by investigator assessment,

  Up to approximately 5 years;

• OS

  Up to approximately 5 years;

• Number of participants with adverse events (AEs),

  Up to approximately 5 years;

Study Arms (1)

SHR-4602

EXPERIMENTAL

Drug: SHR-4602

Interventions

SHR-4602 DRUG

SHR-4602

SHR-4602

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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;
• 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；

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Central Study Contacts

Fan Liang

CONTACT

+86 13761090346; fan.liang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

CN (1)