A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer

NCT06512051 | Recruiting Phase 1

• 1 other identifier: SHR-A2102-205
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Non-small cell lung Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Non-small cell lung Cancer

Conditions

Advanced or Metastatic Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• RP2D

  RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages；

  through phase IB completion, an average of 1 years

• Incidence and severity of AE(DLT)

  According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose；

  from Day1 to 90 days after last dose

• ORR

  efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1

  18 months after the last subject was enrolled in the group

Secondary Outcomes (4)

• DCR

  18 months after the last subject was enrolled in the group

• DOR

  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

Study Arms (2)

Treatment group A

EXPERIMENTAL

SHR-A2102+Adebrelimab+Cisplatin/Carboplatin

Drug: SHR-A2102 for Injection; Drug: Adebrelimab Injection; Drug: Cisplatin injection; Drug: Carboplatin injection

Treatment group B

EXPERIMENTAL

SHR-A2102+Adebrelimab+Bevacizumab

Drug: SHR-A2102 for Injection; Drug: Adebrelimab Injection; Drug: Bevacizumab Injection

Interventions

Adebrelimab Injection DRUG

Adebrelimab injection.

Treatment group A; Treatment group B

Cisplatin injection DRUG

Cisplatin injection.

Treatment group A

Carboplatin injection DRUG

Carboplatin injection.

Treatment group A

Bevacizumab Injection DRUG

Bevacizumab injection.

Treatment group B

SHR-A2102 for Injection DRUG

Drug: SHR-A2102 for injection.

Treatment group A; Treatment group B

Eligibility Criteria

• Age: 18 Years - 70 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 18 -70 years, regardless of gender.
• Provide archived or fresh tumor tissue for vendor test.
• At least one measurable lesion according to RECIST v1.1 criteria.
• Patients with locally advanced or metastatic non-small cell lung cancer who have been confirmed by histological or cytological examination to be inoperable and unable to undergo radical radiotherapy or chemotherapy.
• The ECOG score is 0 or 1.
• Expected survival ≥12 weeks.
• 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:

• Active or symptomatic brain metastases.
• With the exception of patients diagnosed with any other malignancy, except those who have achieved complete remission at least 5 years prior to screening and have ended adjuvant therapy, can be treated locally and have a clear medical record of cure, such as basal cell or squamous cell carcinoma of the skin, superficial bladder cancer in situ, carcinoma in situ of the cervix, breast ductal carcinoma in situ, and papillary carcinoma of the thyroid.
• Uncontrollable moderate to large amounts of pleural effusion, peritoneal effusion or pericardial effusion.
• Patients with uncontrolled tumor-related pain .
• Have antitumor therapy was received 4 weeks before the start of the study.
• Perform non-chest radiation therapy with \>30 Gy within 28 days before dosing, chest radiation therapy with \>30 Gy within 24 weeks before first dosing, and radiation therapy with ≤30 Gy within 14 days before first dosing.
• Subjects who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or the 5 half-life of the investigational drug, whichever is longer.
• Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period.
• Systemic immunosuppressive therapy was administered within 14 days prior to the first study.
• Subjects with a prior history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, and currently known or suspected interstitial pneumonia/non-infectious pneumonia.
• The presence of any active, known or suspected autoimmune disease.
• Subjects with severe cardiovascular and cerebrovascular diseases.
• Subjects who had a severe infection within 28 days prior to the first dose
• Active hepatitis B or active hepatitis C.
• Patients with active pulmonary tuberculosis within 1 year prior to enrolment.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Injections; Cisplatin; Carboplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yunfei Zhang

CONTACT

0518-82342973; yunfei.zhang.yz277@hengrui.com

Study Design

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

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CN (1)