Solid TumorPhase 2NCT07432295
Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
A Phase 2 study testing Givastomig, Nivolumab and 5Fluorouracil in people with Solid Tumor and Advanced Cancer, run by I-Mab Biopharma US Limited at 6 sites in 3 countries.
Trial summary
The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and/or esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. 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?
- Givastomig, Nivolumab and 5Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 11 Feb 2026to Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).
- Treatment-naïve for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy allowed if ≥6 months since last dose).
- CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).
- PD-L1 positive (CPS ≥1).
- At least 1 measurable lesion per RECIST v1.1.
- ECOG performance status 0 or 1.
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- Adequate organ function, including:
- Hematologic: WBC ≥2,000/μL; ANC ≥1,500/μL; platelets ≥100,000/μL; hemoglobin ≥9 g/dL
- Hepatic: AST/ALT ≤3×ULN (≤5×ULN if liver metastases); bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's)
- Renal: Creatinine ≤1.5×ULN or eGFR ≥50 mL/min/1.73 m²
- Life expectancy ≥90 days.
- Women of childbearing potential (WOCBP) and men must use effective contraception during the study and for a defined period after treatment.
- Willing and able to provide informed consent and comply with study procedures
Who cannot join
- HER2-positive tumors.
- Second malignancy within 3 years, except certain skin or cervical cancers.
- Active or unstable gastrointestinal ulcer or bleeding within 6 weeks.
- Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy.
- Active pneumonitis or history requiring steroids/immunosuppressive therapy within 3 years.
- Participation in another therapeutic clinical trial.
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- Major surgery or significant injury within 4 weeks prior to first dose, or planned major surgery within 6 months.
- Radiotherapy within protocol-specified timeframes without adequate recovery.
- Active CNS metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable).
- Significant cardiovascular disease (NYHA Class 3-4 CHF, recent MI, unstable angina, TIA/stroke, or major cardiac procedures within 6 months).
- Active or uncontrolled HIV, hepatitis B, or hepatitis C infection, or immunodeficiency (controlled infection allowed).
- Receipt of live vaccine within 30 days or other vaccines within 7 days of first dose.
- Active infection requiring parenteral therapy.
- Known hypersensitivity to study drug components (e.g., DPD deficiency).
- Any other condition or laboratory abnormality that, in the investigator's judgment, increases risk or interferes with study participation.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
United States3 sites, 3 recruiting
- Recruiting
I-Mab Site 1002
Boston, Massachusetts, 02114
I-Mab PI - 1002
- Recruiting
I-MAB Site 1005
Duarte, California, 91010
I-MAB PI - 1005
- Recruiting
I-Mab Site 1016
Goodyear, Arizona, 85338
I-Mab PI - 1016
Japan2 sites, 2 recruiting
- Not yet recruiting
I-Mab Site - 4001
Kashiwa
I-Mab PI 4001
- Recruiting
I-Mab Site 4005
Tokyo
I-Mab PI - 4005
About this study
Official title: A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination With Nivolumab and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated CLDN18.2 Positive and PD-1L Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma
The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and/or esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are:
- Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer?
- What toxicities do participants experience when taking givastomig?
Read more
Participants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part.
Up to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks.
Participants will:
- Visit the study treatment center for infusions and/or check-ups and tests every 1-3 weeks
- Report any changes in their symptoms to their study doctors
- Have scans to check for any changes in their cancer every 8-12 weeks
Read the detailed description
This is a randomized, global, open-label, multicenter Phase 2 study evaluating the efficacy and safety of givastomig (TJ033721) in combination with nivolumab and chemotherapy compared with nivolumab and chemotherapy alone in participants with previously untreated, HER2-negative, CLDN18.2-positive, and PD-L1-positive locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (GEA).
Approximately 180 participants will be randomized in a 1:1:1 ratio to one of three treatment arms. Two investigational arms will receive givastomig in combination with nivolumab and chemotherapy, and the control arm will receive nivolumab and chemotherapy alone. Chemotherapy will consist of either modified FOLFOX (mFOLFOX) or CAPOX, administered according to local standard of care. Participants enrolled in the United States, Japan, and South Korea will receive mFOLFOX only. Randomization will be stratified by chemotherapy regimen (mFOLFOX vs CAPOX) and by CLDN18.2 expression level (<75% vs ≥75% of tumor cells with membrane intensity score ≥2+).
Participants in the investigational arms will receive givastomig administered every 2 weeks or every 3 weeks, depending on the chemotherapy regimen. Tumor assessments will be performed at protocol-defined intervals and evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Enrollment of participants with high CLDN18.2 expression (defined as membrane intensity score ≥1+ in ≥75% of tumor cells) will be capped at approximately 50% of the total study population. Enrollment of participants receiving CAPOX will be capped at approximately 30% of the total study population.
Study treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or completion of study treatment, whichever occurs first. The duration of chemotherapy treatment will follow the respective product labeling or local standards of care.
- Conditions
- Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer, Gastroesophageal Junction Carcinoma, Esophageal Adenocarcinoma
- Being tested
- Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
- Medical subject headings
- Neoplasm Metastasis, Stomach Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GivastomigDrug
Also called TJ033721
Givastomig 8mg/kg Q2W IV or 12mg/kg Q3W IV
NivolumabDrug
Q2 or Q3W IV
5FluorouracilDrug
Also called 5-FU
Q2W IV
LeucovorinDrug
Q2W IV
OxaliplatinDrug
Q2W or Q3W IV
CapecitabineDrug
Twice daily x 14 days every 3 weeks PO
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Givastomig Arm 1 Combination | Experimental | Givastomig (IV) 8 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 12 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX Receives: Drug: Givastomig; Drug: Nivolumab; Drug: 5Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Capecitabine |
| Experimental: Givastomig Arm 2 Combination | Experimental | Givastomig (IV) 12 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 18 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX Receives: Drug: Givastomig; Drug: Nivolumab; Drug: 5Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Capecitabine |
| Control: Nivolumab Plus Chemotherapy | Active comparator | Nivolumab in combination with modified FOLFOX (mFOLFOX) or CAPOX Receives: Drug: Nivolumab; Drug: 5Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS), BICR-assessed
Compare PFS between participants receiving givastomig plus nivolumab and chemotherapy versus control (nivolumab plus chemotherapy)
Measured: Up to 5 years
Safety and Tolerability
Incidence, severity, and type of adverse events, including treatment-emergent and immune-related adverse events, graded by NCI CTCAE v5.0
Measured: Throughout treatment and up to 30 days after last dose
Secondary outcomes (14)
Objective Response Rate (ORR), BICR-assessed
Proportion of participants with complete or partial response by RECIST v1.1
Measured: Up to 108 weeks
Duration of Response (DOR), BICR-assessed
Time participants maintain complete or partial response
Measured: Up to 108 weeks
Best Overall Response (BOR), BICR-assessed
Best response achieved during treatment according to RECIST v1.1
Measured: Up to 108 weeks
Overall Survival (OS)
Comparison of overall survival between arms
Measured: Up to 5 years
Optimized Dose of Givastomig
Determine the recommended dose of givastomig in combination with nivolumab and chemotherapy
Measured: Up to 2 years
Peak Plasma Concentration (Cmax) of Givastomig
Cmax will be derived from the PK plasma samples collected
Measured: Up to 2 years
Correlation of baseline CLDN18.2 expression with response and safety measures
Tumor expression of CLDN18.2 will be assessed at baseline and will be correlated with measures of response (including ORR, PFS, OS) and safety (incidence of AEs)
Measured: Baseline and up to 2 years
Change in serum levels of soluble 4-1BB (s4-1BB) from baseline
Serum s4-1BB levels will be assessed at baseline and while on treatment. Changes will be correlated with efficacy measures including ORR.
Measured: Baseline and up to 2 years
Health Related Quality of Life (HRQoL) measured by the Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)
The EORTC QLQ-C30 is a cancer specific instrument consisting of 5 functional domain scales: physical, role, emotional, social, and cognitive
Measured: Baseline and up to 2 years
Trough Plasma Concentration (Ctrough) of Givastomig
Ctrough will be derived from the PK plasma samples collected
Measured: Up to 2 years
Number of participants positive for anti-drug antibody (ADA) to Givastomig
Immunogenicity will be measured by the number of participants that are ADA positive
Measured: Up to 2 years
Correlation of baseline PDL1 expression with response and safety measures
Tumor expression of PDL1 will be assessed at baseline and will be correlated with measures of response (including ORR, PFS, OS) and safety (incidence of AEs)
Measured: Baseline and up to 2 years
HRQoL measured by the Oesophago-Gastric Module (EORTC QLQ-OG25) questionnaire
The EORTC-QLQ-OG25 questionnaire evaluates gastric cancer and gastroesophageal cancer specific symptoms
Measured: Baseline and up to 2 years
HRQoL measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
he EQ-5D-5L questionnaire is a validated measure of generic health outcomes including mobility, self-care, usual activities, pain/depression, and anxiety/depression
Measured: Baseline and up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start11 Feb 2026
- Primary completionMar 2030 (estimated)
- Study completionAug 2030 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I-Mab Biopharma US Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432295
- Sponsor's protocol ID
- IMAB033721GCA201
- Status last verified
- May 2026
- First submitted
- 11 Feb 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination With Nivolumab and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated CLDN18.2 Positive and PD-1L Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07432295
- Acronym / sponsor ID
- IMAB033721GCA201
- Conditions
- Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer, Gastroesophageal Junction Carcinoma, Esophageal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- I-Mab Biopharma US LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and/or esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are:
- Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer?
- What toxicities do participants experience when taking givastomig?
Participants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part.
Up to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks.
Participants will:
- Visit the study treatment center for infusions and/or check-ups and tests every 1-3 weeks
- Report any changes in their symptoms to their study doctors
- Have scans to check for any changes in their cancer every 8-12 weeks
Detailed description
This is a randomized, global, open-label, multicenter Phase 2 study evaluating the efficacy and safety of givastomig (TJ033721) in combination with nivolumab and chemotherapy compared with nivolumab and chemotherapy alone in participants with previously untreated, HER2-negative, CLDN18.2-positive, and PD-L1-positive locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (GEA).
Approximately 180 participants will be randomized in a 1:1:1 ratio to one of three treatment arms. Two investigational arms will receive givastomig in combination with nivolumab and chemotherapy, and the control arm will receive nivolumab and chemotherapy alone. Chemotherapy will consist of either modified FOLFOX (mFOLFOX) or CAPOX, administered according to local standard of care. Participants enrolled in the United States, Japan, and South Korea will receive mFOLFOX only. Randomization will be stratified by chemotherapy regimen (mFOLFOX vs CAPOX) and by CLDN18.2 expression level (<75% vs ≥75% of tumor cells with membrane intensity score ≥2+).
Participants in the investigational arms will receive givastomig administered every 2 weeks or every 3 weeks, depending on the chemotherapy regimen. Tumor assessments will be performed at protocol-defined intervals and evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Enrollment of participants with high CLDN18.2 expression (defined as membrane intensity score ≥1+ in ≥75% of tumor cells) will be capped at approximately 50% of the total study population. Enrollment of participants receiving CAPOX will be capped at approximately 30% of the total study population.
Study treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or completion of study treatment, whichever occurs first. The duration of chemotherapy treatment will follow the respective product labeling or local standards of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Givastomig Arm 1 Combination | Experimental | Drug: Givastomig, Drug: Nivolumab, Drug: 5Fluorouracil, Drug: Leucovorin, Drug: Oxaliplatin, Drug: CapecitabineGivastomig (IV) 8 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 12 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX |
| Experimental: Givastomig Arm 2 Combination | Experimental | Drug: Givastomig, Drug: Nivolumab, Drug: 5Fluorouracil, Drug: Leucovorin, Drug: Oxaliplatin, Drug: CapecitabineGivastomig (IV) 12 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 18 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX |
| Control: Nivolumab Plus Chemotherapy | Active comparator | Drug: Nivolumab, Drug: 5Fluorouracil, Drug: Leucovorin, Drug: Oxaliplatin, Drug: CapecitabineNivolumab in combination with modified FOLFOX (mFOLFOX) or CAPOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).
- Treatment-naïve for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy allowed if ≥6 months since last dose).
- CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).
- PD-L1 positive (CPS ≥1).
- At least 1 measurable lesion per RECIST v1.1.
Key exclusion criteria (15 listed)
- HER2-positive tumors.
- Second malignancy within 3 years, except certain skin or cervical cancers.
- Active or unstable gastrointestinal ulcer or bleeding within 6 weeks.
- Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy.
- Active pneumonitis or history requiring steroids/immunosuppressive therapy within 3 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GivastomigAlso: TJ033721Givastomig 8mg/kg Q2W IV or 12mg/kg Q3W IV | Drug | Experimental: Givastomig Arm 1 Combination, Experimental: Givastomig Arm 2 Combination |
| NivolumabQ2 or Q3W IV | Drug | Control: Nivolumab Plus Chemotherapy, Experimental: Givastomig Arm 1 Combination, Experimental: Givastomig Arm 2 Combination |
| 5FluorouracilAlso: 5-FUQ2W IV | Drug | Control: Nivolumab Plus Chemotherapy, Experimental: Givastomig Arm 1 Combination, Experimental: Givastomig Arm 2 Combination |
| LeucovorinQ2W IV | Drug | Control: Nivolumab Plus Chemotherapy, Experimental: Givastomig Arm 1 Combination, Experimental: Givastomig Arm 2 Combination |
| OxaliplatinQ2W or Q3W IV | Drug | Control: Nivolumab Plus Chemotherapy, Experimental: Givastomig Arm 1 Combination, Experimental: Givastomig Arm 2 Combination |
| CapecitabineTwice daily x 14 days every 3 weeks PO | Drug | Control: Nivolumab Plus Chemotherapy, Experimental: Givastomig Arm 1 Combination, Experimental: Givastomig Arm 2 Combination |
Primary outcome
Progression-Free Survival (PFS), BICR-assessed
Time frame: Up to 5 years
Compare PFS between participants receiving givastomig plus nivolumab and chemotherapy versus control (nivolumab plus chemotherapy)
Safety and Tolerability
Time frame: Throughout treatment and up to 30 days after last dose
Incidence, severity, and type of adverse events, including treatment-emergent and immune-related adverse events, graded by NCI CTCAE v5.0
14 secondary outcomes
Objective Response Rate (ORR), BICR-assessed
Time frame: Up to 108 weeks
Duration of Response (DOR), BICR-assessed
Time frame: Up to 108 weeks
Best Overall Response (BOR), BICR-assessed
Time frame: Up to 108 weeks
Overall Survival (OS)
Time frame: Up to 5 years
Optimized Dose of Givastomig
Time frame: Up to 2 years
Peak Plasma Concentration (Cmax) of Givastomig
Time frame: Up to 2 years
Correlation of baseline CLDN18.2 expression with response and safety measures
Time frame: Baseline and up to 2 years
Change in serum levels of soluble 4-1BB (s4-1BB) from baseline
Time frame: Baseline and up to 2 years
Health Related Quality of Life (HRQoL) measured by the Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)
Time frame: Baseline and up to 2 years
Trough Plasma Concentration (Ctrough) of Givastomig
Time frame: Up to 2 years
Number of participants positive for anti-drug antibody (ADA) to Givastomig
Time frame: Up to 2 years
Correlation of baseline PDL1 expression with response and safety measures
Time frame: Baseline and up to 2 years
HRQoL measured by the Oesophago-Gastric Module (EORTC QLQ-OG25) questionnaire
Time frame: Baseline and up to 2 years
HRQoL measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
Time frame: Baseline and up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Givastomig, Nivolumab and 5Fluorouracil in people with Solid Tumor and Advanced Cancer, run by I-Mab Biopharma US Limited at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Japan, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact I-MAB US Clinical Trials (301-294-4408, us.info@imabbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS), BICR-assessed (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.