Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

Sponsor

I-Mab Biopharma Co. Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04900818

Collaborator

(none)

132

Enrollment

Locations

Arm

32.1

Anticipated Duration (Months)

7.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 in subjects with advanced or metastatic solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Advanced Cancer Metastatic Cancer Gastric Cancer Gastroesophageal Junction Carcinoma Esophageal Adenocarcinoma Pancreatic Ductal Adenocarcinoma	Drug: TJ033721	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

Actual Study Start Date :

Jun 29, 2021

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation: TJ033721 Dose Escalation:: TJ033721 will be administered at up to 8 dose levels (0.1, 0.3, 1, 3, 5, 8, 12 and 15 mg/kg) bi-weekly (Q2W) During dose expansion, TJ033721 will be administered Q2W, starting at the highest dose to have cleared the DLT period. After the conclusion of dose expansion TJ033721 will be administered Q2W at the MAD or RP2D.	Drug: TJ033721 Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)

Arm

Intervention/Treatment

Experimental: Dose Escalation: TJ033721

Dose Escalation:: TJ033721 will be administered at up to 8 dose levels (0.1, 0.3, 1, 3, 5, 8, 12 and 15 mg/kg) bi-weekly (Q2W) During dose expansion, TJ033721 will be administered Q2W, starting at the highest dose to have cleared the DLT period. After the conclusion of dose expansion TJ033721 will be administered Q2W at the MAD or RP2D.

Drug: TJ033721

Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)

Outcome Measures

Primary Outcome Measures

Dose-limiting toxicities (DLTs) [28 days]
Incidence and severity of AEs [Up to 100 days post last dose]
The CTCAE criteria will be used to assess adverse events on this trial.
Maximum tolerated or administered dose (MTD, MAD) [28 Days]
Based on DLT definitions

Secondary Outcome Measures

Pharmacokinetic (PK) Parameters: AUC∞ [Up to 100 days post last dose]
Area under the curve from time zero extrapolated to infinity (AUC∞)
Pharmacokinetic (PK) Parameters: AUCt [up to 100 days post last dose]
AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
Pharmacokinetic (PK) Parameters: Cmax [up to 100 days post last dose]
Maximum observed concentration
Pharmacokinetic Parameters: Tmax [up to 100 days post last dose]
Time of peak concentration (Tmax)
Pharmacokinetic Parameters: T1/2 [up to 100 days post last dose]
Investigational Product (IP) half-life (T1/2)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function

For dose expansion study only:

Advanced or metastatic gastric cancer, gastroesophageal junction carcinoma, esophageal adenocarcinoma, and pancreatic ductal adenocarcinoma without further standard therapy or unsuitable for available standard treatment options.
Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay

Exclusion Criteria

Prior exposure to CLDN18.2 -targeted therapy
Prior exposure to 4-1BB agonists
Known active or chronic Hepatitis B or Hepatitis C, other hepatitides
Unstable/active ulcer or digestive tract bleeding within 6 weeks
Active autoimmune disease requiring systemic treatment within the past 2 years
Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment
Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;
New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe/unstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), deep vein thrombosis, or coronary artery bypass grafting (CABG) in the previous 6 months
Diagnosis of immunodeficiency such as known active HIV

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stern Center for Cancer Clinical Trials and Research	Orange	California	United States	92868
2	UCHealth Cancer Care - Anschutz Medical Campus	Aurora	Colorado	United States	80045
3	Horizon Oncology Research, LLC.	Lafayette	Indiana	United States	47905
4	Mass General Hospital	Boston	Massachusetts	United States	02114
5	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Carolina BioOncology Institute	Huntersville	North Carolina	United States	28078
8	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232
9	Mary Crowley Cancer Research	Dallas	Texas	United States	75230
10	UW Carbone Cancer Center	Madison	Wisconsin	United States	53705
11	Beijing Cancer Hospital	Beijing	Beijing	China	100142
12	Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510655
13	Henan Cancer Hospital	Zhengzhou	Henan	China	45003
14	Hubei Cancer Hospital	Wuhan	Hubei	China	430079
15	The First Hospital of China Medical University	Shenyang	Liaoning	China	110499
16	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032
17	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin	China	300060
18	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hongzhou	Zhejiang	China	3110020

Sponsors and Collaborators

I-Mab Biopharma Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

I-Mab Biopharma Co. Ltd.

ClinicalTrials.gov Identifier:

NCT04900818

Other Study ID Numbers:

TJ033721STM101

First Posted:

May 25, 2021

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of Aug 10, 2022