A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors

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• Lung Neoplasms 7,243
• Stomach Neoplasms 2,851

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 170 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Lead sponsor

This is the only study on the registry with 3H Pharmaceuticals Co., Ltd. as lead sponsor.

Study arms

• Experimental
  Stage I - dose escalation

  Dose escalation of 3H-10000 in patients with advanced solid tumors.

  Drug: 3H-10000

• Experimental
  stage II - expansion

  Expansion evaluating the recommended dose and schedule of 3H-10000 identified from Stage I.

  Drug: 3H-10000

Interventions

• Drug3H-10000

  3H-10000 will be administered by infusion Q2W in 28-day cycles.

Primary outcomes

1. Dose Escalation Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

   Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0)), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria and AEs meeting protocol-defined adverse event of clinical interest (AECIs)

   Time frame: Up to approximately 2 years

2. Dose Escalation Phase：Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of 3H-10000

   The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate, or the highest dose administered, respectively.

   Time frame: Up to approximately 2 years

3. Dose Escalation Phase：The recommended Phase 2 dose (RP2D) of 3H-10000

   The RP2D of 3H-10000 monotherapy will be determined based on relevant data, as available

   Time frame: Up to approximately 2 years

4. Efficacy Expansion Phase：Overall Response Rate (ORR)

   ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

   Time frame: Up to approximately 2 years

Secondary outcomes

1. Dose Escalation Phase：ORR

   ORR is defined as the percentage of participants with CR or PR, as determined by RECIST v1.1

   Time frame: Up to approximately 2 years

2. Dose Escalation Phase and Efficacy Expansion Phase：Disease Control Rate (DCR)

   DCR is defined as the percentage of participants with best overall response of a CR, PR, and stable disease, as assessed by RECIST v1.1

   Time frame: Up to approximately 2 years

3. Dose Escalation Phase and Efficacy Expansion Phase：Duration of Response (DOR)

   DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever comes first, as assessed using RECIST v1.1

   Time frame: Up to approximately 2 years

4. Efficacy Expansion Phase：Progression Free Survival (PFS)

   PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed using RECIST v1.1 or death, whichever occurs first

   Time frame: Up to approximately 2 years

5. Efficacy Expansion Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

   Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0), and AEs meeting protocol-defined adverse event of clinical interest (AECI)s.

   Time frame: Up to approximately 2 years

6. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

   AUC0-last

   Time frame: Twice in the first 3 months

7. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

   AUC0-inf

   Time frame: Twice in the first 3 months

8. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

   Cmax

   Time frame: Twice in the first 3 months

9. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

   Tmax

   Time frame: Twice in the first 3 months

10. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Ctrough

    Time frame: Twice in the first 3 months

11. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    CL

    Time frame: Twice in the first 3 months

12. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    t1/2

    Time frame: Twice in the first 3 months

13. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Vd

    Time frame: Twice in the first 3 months

14. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Vss

    Time frame: Twice in the first 3 months

15. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    AUC0-last

    Time frame: Up to approximately 2 years

16. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    AUC0-inf

    Time frame: Up to approximately 2 years

17. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Cmax

    Time frame: Up to approximately 2 years

18. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Tmax

    Time frame: Up to approximately 2 years

19. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Ctrough

    Time frame: Up to approximately 2 years

20. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    CL

    Time frame: Up to approximately 2 years

21. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    t1/2

    Time frame: Up to approximately 2 years

22. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Vd

    Time frame: Up to approximately 2 years

23. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Vss

    Time frame: Up to approximately 2 years