A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors

NCT06417554 | Recruiting Phase 1

• 1 other identifier: SHR-A2102-201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with or without Antitumor Therapy in Advanced Solid Tumors. To explore the reasonable dosage of SHR-A2102 for Advanced Solid Tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• RP2D

  through phase IB completion, an average of 1 years

• Incidence and severity of AE；

  from Day1 to 90 days after last dose

• ORR

  18 months after the last subject was enrolled in the group

Secondary Outcomes (8)

• DCR(Investigator evaluation)

  18 months after the last subject was enrolled in the group

• DoR(Investigator evaluation)

  18 months after the last subject was enrolled in the group

• PFS(Investigator evaluation)

  18 months after the last subject was enrolled in the group

• OS(Investigator evaluation)

  18 months after the last subject was enrolled in the group

• SHR-A2102 and free toxin PK

  through study completion, an average of 2 years

Study Arms (2)

Treatment group A: SHR-A2102 + Adebrelimab injection

EXPERIMENTAL

Drug: SHR-A2102 ; Adebrelimab injection

Treatment group B: SHR-A2102

EXPERIMENTAL

Drug: SHR-A2102

Interventions

SHR-A2102 DRUG

SHR-A2102

Treatment group B: SHR-A2102

SHR-A2102 ; Adebrelimab injection DRUG

SHR-A2102 + Adebrelimab injection

Treatment group A: SHR-A2102 + Adebrelimab injection

Eligibility Criteria

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

You may qualify if:

• 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；
• The age of signing the informed consent is above 18 years old, regardless of gender；
• The ECOG score is 0 or 1；
• Expected survival ≥12 weeks
• Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, stage Ib subjects who have failed standard treatment; Stage II subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors without systemic antitumor therapy；
• Provide archived or fresh tumor tissue；
• At least one measurable lesion according to RECIST v1.1 criteria；
• Good level of organ function；
• Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods

You may not qualify if:

• Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；
• Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors; Stage II was previously treated with PD-1/PD-L1 inhibitors；
• Systemic antitumor therapy was received 4 weeks before the start of the study；
• Palliative radiotherapy was completed within 14 days before the first dose; Chest radiotherapy \>30 Gy within 6 months prior to initial administration；
• Systemic immunosuppressive therapy was administered within 14 days prior to the first study；
• Subjects with known or suspected interstitial pneumonia；
• ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors；
• The presence of any active, known, or suspected autoimmune disease；
• 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；
• Any other malignancy diagnosed within the previous 5 years；
• Subjects who had a severe infection within 28 days prior to the first dose；
• Active hepatitis B or active hepatitis C；
• 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；

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Central Study Contacts

Chi Zhang

CONTACT

+8618456513908; chi.zhang@hengrui.com

Study Design

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

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 16, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 31, 2024

Record last verified: 2024-04

Locations

CN (1)