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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 Phase 1, Phase 2 156 Open-Label

Not yet recruiting
Clinical Trial NCT06474455 is designed to study Treatment for Advanced Solid Tumors. This Phase 1 Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 June 2024 until the study accrues 156 participants. Led by Shanghai Hengrui Pharmaceutical Co., Ltd., this study is expected to complete by 1 June 2027. The latest data from ClinicalTrials.gov was last updated on 25 June 2024.
Brief Summary
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.
Official Title

A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-9839 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors

Conditions
Advanced Solid Tumors
Other Study IDs
  • SHR-9839-201
NCT ID Number
NCT06474455
Start Date (Actual)
2024-06
Last Update Posted
2024-06-25
Completion Date (Estimated)
2027-06
Enrollment (Estimated)
156
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSHR-9839 combined with SHR-A2009
SHR-9839 ；SHR-A2009
SHR-9839 combined with SHR-A2009
ExperimentalSHR-9839 combined with SHR-A1921
SHR-9839 ； SHR-A1921
SHR-9839 combined with SHR-A1921
ExperimentalSHR-9839 combined with pemetrexed + carboplatin
SHR-9839 ； pemetrexed ；carboplatin
SHR-9839 combined with pemetrexed + carboplatin
ExperimentalSHR-9839 combined with Almonertinib
SHR-9839 ； Almonertinib
SHR-9839 combined with Almonertinib
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence of dose-limiting toxicity (DLT) (phase IB)
21 days after the first dose was administered to each subject，Up to approximately 24 months.
Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase IB)
Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0)
Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 24 months.
Objective Response Rate (ORR) (phase II).
Evaluated using RECIST 1.1
The first treatment lasted until disease progression，Up to approximately 24 months.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II)
Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0)
Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 24 months.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
Shanghai Hengrui Pharmaceutical Co., Ltd. logoShanghai Hengrui Pharmaceutical Co., Ltd.
Study Central Contact
Contact: Qingkai Zhou, +8618205139261, [email protected]
2 Study Locations in 1 Countries

HangZhou

Zhejiang Cancer Hospital, Zhejiang, HangZhou, 310005, China
Zhengbo Song, Principal Investigator

Henan

HeNan CANCER HOSPITAL, Zhenzhou, Henan, 450003, China
QiMing Wang, Principal Investigator