Solid TumorPhase 1NCT04900818
Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1 study testing TJ033721 (givastomig), TJ033721 (givastomig) , nivolumab, chemotherapy and TJ033721 (givastomig), chemotherapy in people with Solid Tumor and Advanced Cancer, run by I-Mab Biopharma US Limited at 21 sites in 2 countries.
Trial summary
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Advanced Cancer, Metastatic Cancer
- What is being tested?
- TJ033721 (givastomig), TJ033721 (givastomig) , nivolumab, chemotherapy and TJ033721 (givastomig), chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 29 Jun 2021to Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1 - Monotherapy 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.
- Part 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma;
- Part 3: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma;
- Part 4: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed biliary tract cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function
- Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)
- For dose expansion and Part 2, Part 3, Part 4 Combination subjects:
- Must have CLDN18.2-positive tumor expression
Who cannot join
- Prior exposure to CLDN18.2 -targeted therapy
- Prior exposure to 4-1BB agonists
- Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ
- 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
Show all 13Show fewer
- 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, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months
- Diagnosis of immunodeficiency such as known active HIV
- Any active infection requiring parenteral treatment
- For Part 2, 3, 4 Combination subjects:
- Prior treatment with anti-PD-1 or PD-L1 agent
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 2 countries
United States11 sites, 6 recruiting
- Recruiting
UCHealth Cancer Care - Anschutz Medical Campus
Aurora, Colorado, 80045
- Recruiting
Mass General Hospital
Boston, Massachusetts, 02114
- Completed
Mary Crowley Cancer Research
Dallas, Texas, 75230
- Completed
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
- Completed
Horizon Oncology Research, LLC.
Layfayette, Indiana, 47905
- Recruiting
UW Carbone Cancer Center
Madison, Wisconsin, 53705
- Completed
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
- Completed
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
- Recruiting
NYU Langone
New York, New York, 10016
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Stern Center for Cancer Clinical Trials and Research
Orange, California, 92868
China10 sites, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Active, not recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
- Completed
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 3110020
- Completed
HARBIN Medical University Cancer Hospital
Harbin, Heilongjiang, 150086
- Withdrawn
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
- Completed
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
- Completed
The First Hospital of China Medical University
Shenyang, Liaoning, 110499
- Completed
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
- Completed
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Completed
Henan Cancer Hospital
Zhengzhou, Henan, 45003
About this study
Official title: A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.
- Conditions
- Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer, Gastroesophageal Junction Carcinoma, Esophageal Adenocarcinoma
- Being tested
- TJ033721 (givastomig), TJ033721 (givastomig) , nivolumab, chemotherapy, TJ033721 (givastomig), chemotherapy, TJ033721 (givastomig), durvalumab, chemotherapy
- Medical subject headings
- Neoplasm Metastasis, Stomach Neoplasms, Adenocarcinoma Of Esophagus, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ033721 (givastomig)Drug
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
TJ033721 (givastomig) , nivolumab, chemotherapyDrug
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy
TJ033721 (givastomig), chemotherapyDrug
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy
TJ033721 (givastomig), durvalumab, chemotherapyDrug
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| TJ033721 (givastomig) | Experimental | 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) and 1 dose level (18 mg/kg) every 3 weeks (Q3W)
During dose expansion, TJ033721 will be administered Q2W, starting at the RP2D or MTD in dose escalation. Receives: Drug: TJ033721 (givastomig) |
| TJ033721 (givastomig) in combination with nivolumab and chemotherapy | Experimental | TJ033721 will be administered in combination with nivolumab and chemotherapy Receives: Drug: TJ033721 (givastomig) , nivolumab, chemotherapy |
| TJ033721 (givastomig) in combination chemotherapy | Experimental | TJ033721 (givastomig) will be administered in combination chemotherapy Receives: Drug: TJ033721 (givastomig), chemotherapy |
| TJ033721 (givastomig) in combination with durvalumab and chemotherapy | Experimental | TJ033721 (givastomig) will be administered in combination with durvalumab and chemotherapy Receives: Drug: TJ033721 (givastomig), durvalumab, chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs)
Measured: 28 days
Incidence and severity of AEs
The CTCAE criteria will be used to assess adverse events on this trial.
Measured: Up to 100 days post last dose
Maximum tolerated or administered dose (MTD, MAD)
Based on DLT definitions
Measured: 28 Days
Secondary outcomes (5)
Pharmacokinetic (PK) Parameters: AUC∞
Area under the curve from time zero extrapolated to infinity (AUC∞)
Measured: Up to 100 days post last dose
Pharmacokinetic (PK) Parameters: AUCt
AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
Measured: up to 100 days post last dose
Pharmacokinetic (PK) Parameters: Cmax
Maximum observed concentration
Measured: up to 100 days post last dose
Pharmacokinetic Parameters: Tmax
Time of peak concentration (Tmax)
Measured: up to 100 days post last dose
Pharmacokinetic Parameters: T1/2
Investigational Product (IP) half-life (T1/2)
Measured: up to 100 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start29 Jun 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I-Mab Biopharma US Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900818
- Sponsor's protocol ID
- TJ033721STM101
- Status last verified
- Mar 2026
- First submitted
- 20 May 2021
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No