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A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

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Hengrui Medicine

Status and phase

Not yet enrolling
Phase 2
Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: SHR-9839 ; Almonertinib
Drug: SHR-9839 ;SHR-A2009
Drug: SHR-9839 ; pemetrexed ;carboplatin
Drug: SHR-9839 ; SHR-A1921

Study type

Interventional

Funder types

Industry

Identifiers

NCT06474455
SHR-9839-201

Details and patient eligibility

About

This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.

Enrollment

156 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Aged 18-75 years old (inclusive), regardless of gender.
  2. Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology,.
  3. At least one measurable tumor lesion according to RECIST v1.1.
  4. ECOG performance score of 0-1.
  5. Life expectancy ≥ 12 weeks.
  6. Adequate bone marrow and organ function.
  7. Have the ability to informed consent, have signed the IRB / EC approved informed consent and dated, willing and able to comply with the treatment plan to visit the inspection and other procedural requirements.

Exclusion criteria

  1. Patients with active central nervous system ( CNS ) metastases.
  2. Spinal cord compression not be cured by surgery or radiotherapy.
  3. Subjects with uncontrollable tumor-related pain.
  4. Clinically uncontrollable the third space effusion.
  5. Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
  6. Received > 30Gy chest radiotherapy within 24 weeks prior to the first dose of study drug.
  7. Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug.
  8. Concomitant other malignancies ≤ 3 years prior to the first dose of study drug.
  9. History of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis or inability to exclude interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function.
  10. Serious cardiovascular and cerebrovascular diseases.
  11. Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug.
  12. History of immunodeficiency, including HIV test positive.
  13. Active hepatitis B or hepatitis C infection.
  14. History of severe allergic reactions to any component of any study drug to be accepted.
  15. Known history of alcohol or drug dependence.
  16. Mental disorders or poor compliance ;
  17. Pregnant or lactating women.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

156 participants in 4 patient groups

SHR-9839 combined with SHR-A2009
Experimental group
Treatment:
Drug: SHR-9839 ;SHR-A2009
SHR-9839 combined with SHR-A1921
Experimental group
Treatment:
Drug: SHR-9839 ; SHR-A1921
SHR-9839 combined with pemetrexed + carboplatin
Experimental group
Treatment:
Drug: SHR-9839 ; pemetrexed ;carboplatin
SHR-9839 combined with Almonertinib
Experimental group
Treatment:
Drug: SHR-9839 ; Almonertinib

Trial contacts and locations

2

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Central trial contact

Qingkai Zhou

Data sourced from clinicaltrials.gov

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