A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors

NCT06092268 | Unknown Phase 1

• 1 other identifier: SHR-A2009-201
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicity (DLT) (phase IB)

  21 days after the first dose was administered to each subject.

• Objective Response Rate (ORR) (phase II).

  2 years

Secondary Outcomes (11)

• PK parameter: toxin-binding antibody of SHR-A2009

  through study completion, an average of 2 years

• PK parameter: total antibody of SHR-A2009

  through study completion, an average of 2 years

• PK parameter: free toxin of SHR-A2009

  through study completion, an average of 2 years

• Plasma concentration of Adebrelimab

  through study completion, an average of 2 years

• Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)

  through study completion, an average of 2 years

Study Arms (2)

Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets

EXPERIMENTAL

Drug: SHR-A2009 for injection ； Almonertinib Mesilate Tablets

Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection

EXPERIMENTAL

Drug: SHR-A2009 for injection；Adebrelimab Injection

Interventions

SHR-A2009 for injection ； Almonertinib Mesilate Tablets DRUG

Phase IB: SHR-A2009 will be administered intravenously，Almonertinib Mesilate Tablets will be administered orally. 2 or 3 dose levels are preset in phase IB. Phase II: 2 dose cohorts will be selected and it's randomization.

Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets

SHR-A2009 for injection；Adebrelimab Injection DRUG

Phase IB: SHR-A2009 and Adebrelimab will be administered intravenously. 2 dose levels are preset in phase IB. Phase II: RPD2 will be selected to evaluate preliminary efficacy.

Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years old (inclusive), Female or male
• Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
• Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
• At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase)
• ECOG performance score of 0-1;
• Expected survival time ≥ 12 weeks;
• Adequate bone marrow and organ function
• Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.

You may not qualify if:

• Subjects with active central nervous system (CNS) metastases.
• Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
• Subjects with uncontrolled tumor-related pain
• Clinically uncontrollable third space fluid
• Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
• Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
• Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
• Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
• Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
• Serious cardiovascular disease
• Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases
• Presence of severe infection within 4 weeks prior to first dose of study drug
• Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug
• Arterial/venous thrombotic events within 3 months prior to the first study dose
• History of immunodeficiency, including a positive HIV test

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Central Study Contacts

Fei Qiu

CONTACT

0518-82342973; fei.qiu@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: October 8, 2023
• First Posted: October 23, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10