FIH Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation in China

Sponsor
Jacobio Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05009329
Collaborator
(none)
144
1
2
52.2
2.8

Study Details

Study Description

Brief Summary

To assess safety, tolerability, PK, preliminary efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

This is a phase 1/2a, first-in-human, open-label study of JAB-21822, this study has two parts: dose escalation phase and dose expansion phase.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12c Mutations
Actual Study Start Date :
Jul 26, 2021
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 1 Dose Exploration

Dose escalation of JAB-21822 to determine maximum tolerated dose

Drug: JAB-21822
JAB-21822 will be administered orally

Experimental: Phase 1 Dose Expansion

Conditionally required

Drug: JAB-21822
JAB-21822 will be administered orally

Outcome Measures

Primary Outcome Measures

  1. Incidence of dose limiting toxicities (DLTs) in the dose escalation phase [first 21 days]

    Number of participants with dose limiting toxicities

  2. Number of participants with adverse events [up to 4 years]

    Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria

Secondary Outcome Measures

  1. Peak Plasma Concentration (Cmax) [up to 4 years]

    Cmax of JAB-21822 will be measured by using plasma PK samples

  2. Area under plasma concentration versus time curve (AUC) [up to 4 years]

  3. Objective response rate ( ORR ) [up to 4 years]

    ORR is defined as the proportion of participants with complete response or partial response (CR+PR) per RECIST v 1.1

  4. Duration of response ( DOR ) [up to 4 years]

    DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.

  5. Disease Control Rate ( DCR ) [up to 4 years]

    DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease(SD) per CTCAE v1.1

  6. Progression-free survival (PFS) [up to 4 years]

    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Written informed consent

  2. Advanced (metastatic or unresectable) KRAS G12C mutant solid tumors, with failure or absence of standard treatment

  3. Subject must be ≥18 years

  4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

  5. Subjects with life expectancy ≥3 months.

  6. Subjects must have at least one measurable lesion as defined by RECIST v1.1.

  7. There was no serious organ dysfunction in the screening stage

  8. Male or female subjects of reproductive age agree to use adequate contraception

Exclusion Criteria:
  1. History of intestinal disease or major gastric surgery or inability to swallow oral medications

  2. Other active cancer

  3. Previously treated with KRAS G12C inhibitor

  4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)

  5. Impaired heart function or clinically significant heart disease

  6. Pregnant or breast-feeding

  7. Previous allogeneic bone marrow transplant or organ transplant

  8. Intended study subjects who were unable to abstain from alcohol during medication

  9. Other unqualified conditions judged by the investigators

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China 100142

Sponsors and Collaborators

  • Jacobio Pharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05009329
Other Study ID Numbers:
  • JAB-21822-1002
First Posted:
Aug 17, 2021
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jacobio Pharmaceuticals Co., Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2021