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Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

Sponsor
Jacobio Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05288205
Collaborator
(none)
124
Enrollment
24
Locations
2
Arms
46.6
Anticipated Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
Actual Study Start Date :
Apr 14, 2022
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose escalation

Drug: JAB-21822
KRAS G12C inhibitor

Drug: JAB-3312
SHP2 inhibitor
Experimental: Dose expansion

Drug: JAB-21822
KRAS G12C inhibitor

Drug: JAB-3312
SHP2 inhibitor

Outcome Measures

Primary Outcome Measures

  1. recommended phase-2 dose (RP2D). [Approximately 2 years]

    RP2D should be selected based on a comprehensive assessment of maximum tolerated dose(MTD), toxicity, pharmacokinetic(PK) profile, and efficacy data.

  2. Number of participants with dose limiting toxicities [Approximately 2 years]

    Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically significant abnormal laboratory value occurring in Cycle 1 (DLT assessment period), which is unrelated to progressive disease, concurrent disease, or concomitant medication but related to JAB-21822 and/or JAB-3312, and meets the criteria for DLT.

Secondary Outcome Measures

  1. Number of participants with AEs [Approximately 2 years]

    All patients participating in this study will be assessed for incidence and severity of AEs and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imagings and ophthalmological assessments

  2. Objective response rate (ORR) [Approximately 2 years]

    ORR is defined as the proportion of participants with confirmed complete response or partial response

  3. Progression-free survival (PFS) [Approximately 2 years]

    Period of time from the start of treatment to tumor progression or death from any cause (whichever occurs first) based on RECIST v1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;

  • Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors who have failed or lack standard-of-care (SOC) or are unwilling to undergo or intolerant to SOC; those with solid tumors harboring KRAS p.G12C mutation are preferred;

  • Expected survival ≥ 3 months;

  • Subjects must have at least one measurable lesion as defined by RECIST v1.1. If no measurable lesion untreated with radiation is selected as the target lesion, a lesion treated with radiation ≥ 4 weeks before the first dose and with progression conformed by radiography may be selected as the target lesion;

  • Eastern Cooperative Oncology Group(ECOG) performance status 0-1;

  • The organ functions of subjects meet the criteria for the following laboratory parameters at screening;

  • Subjects must be able to swallow oral medications without gastrointestinal abnormalities that significantly affect drug absorption

Exclusion Criteria:

  • Patients with previous (≤ 3 years) or current tumors of other pathological types, except for cured cervical carcinoma in situ, ductal carcinoma in situ of the breast, prostatic intraepithelial neoplasia, superficial non-invasive bladder cancer, stage I skin cancer (except melanoma); subjects without recurrence or metastasis for > 3 years after treatment, without current evidence of tumor, and without significant risk of recurrence of previous malignant diseases in the opinion of the study doctor may also be enrolled;

  • Serious allergy to the investigational drug or excipients (such as microcrystalline cellulose, etc.);

  • Patients with previous (≤ 6 months before the initiation of treatment) or current severe autoimmune diseases (including adverse reactions caused by previous anti- tumor immunotherapies), or autoimmune diseases requiring long-term systemic hormone therapy at immunosuppressive dose levels (prednisone > 10 mg/day or equivalent drugs);

  • HIV, hepatitis B virus(HBV), or hepatitis C virus(HCV) positive;

  • Previous (≤ 6 months prior to the first dose) or current evidence of the following diseases: acute myocardial infarction, unstable angina and cerebrovascular accident;

  • Subjects who have impaired cardiac functions or clinically significant cardiac diseases;

  • Pregnant or lactating women

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pecking Union Medical College Hospital Beijing Beijing China 100005
2 Cancer Hospital Chinese Academy Of Medical Sciences Beijing Beijing China 100021
3 Beijing Tiantan Hospital, Captal Medical University Beijing Beijing China 100070
4 Beijing Cancer Hospital Beijing Beijing China 100142
5 Peking University Third Hospital Beijing Beijing China 100191
6 Beijing Chest Hospital, Capital Medical University Beijing Beijing China 101125
7 Fujian cancer Hospital Fuzhou Fujian China 350014
8 Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center Shenzhen Guangdong China 518116
9 Harbin Medical University Cancer Hospital-Mammary gland of internal Ha'erbin Heilongjiang China 150081
10 Henan Cancer Hospital Zhengzhou Henan China 450003
11 Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei China 430022
12 Tongji Hospital Tongji Medical College of Hust Wuhan Hubei China 430030
13 Renmin Hospital Of Wuhan University Wuhan Hubei China 430060
14 Xiangya Hospital Central South Univesity Changsha Hunan China 410008
15 Hunan Cancer Hospital Changsha Hunan China 410031
16 The Second Hospital of Dalian Medical University Dalian Liaoning China 116023
17 The First Hospital Of China Medical University Shenyang Liaoning China 110001
18 Liaoning Cancer Hospital & Institute Shenyang Liaoning China 110801
19 The Affilated Hospital of Inner Mongolia Medical University Hohhot Neimenggu China 750306
20 Qilu Hospital of Shandong University Jinan Shandong China 250012
21 Shandong Cancer Hospital Jinan Shandong China 250117
22 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032
23 The First Affiliated Hospital of Xi'An Jiaotong University Xi'an Shanxi China 710061
24 West China Hospital Sichuan University Chendu Sichuan China 610044

Sponsors and Collaborators

  • Jacobio Pharmaceuticals Co., Ltd.

Investigators

  • Study Director: Jacobio Pharmaceuticals, Jacobio Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05288205
Other Study ID Numbers:
  • JAB-21822-1006
First Posted:
Mar 21, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
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
Additional relevant MeSH terms:
Carcinoma, Ductal
Carcinoma, Pancreatic Ductal

Study Results

No Results Posted as of Jun 30, 2022