This section highlights FDA-related milestones and regulatory updates for drugs developed by I-Mab (IMAB).
Over the past two years, I-Mab has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Givastomig and TJ-CD4B. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Givastomig FDA Regulatory Timeline and Events
Givastomig is a drug developed by I-Mab for the following indication: In patients with advanced cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Givastomig
- Announced Date:
- August 11, 2025
- Indication:
- In patients with advanced cancers
Announcement
I-Mab announced that enrollment in the planned Phase 1b dose expansion cohorts evaluating givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, in combination with nivolumab and mFOLFOX6, has been completed ahead of expectations.
AI Summary
I-Mab announced the early completion of enrollment in its Phase 1b dose expansion cohorts for givastomig, a bispecific Claudin 18.2 × 4-1BB antibody, combined with nivolumab and mFOLFOX6. The U.S. study enrolled 40 patients divided between 8 mg/kg and 12 mg/kg doses ahead of schedule.
The trial, focused on first-line treatment for Claudin 18.2-positive gastric cancer, aims primarily to assess safety. Topline results are expected in Q1 2026. Investigators’ rapid recruitment reflects a strong interest in novel immunotherapy combinations to address this cancer’s high unmet need.
Earlier Phase 1b dose escalation data presented at ESMO GI 2025 demonstrated an 83% objective response rate in 12 patients, with quick, deep, and durable tumor reductions alongside a favorable safety profile. These promising results underscore givastomig’s potential as a new treatment option for gastric cancer patients.
Read Announcement- Drug:
- Givastomig
- Announced Date:
- July 2, 2025
- Indication:
- In patients with advanced cancers
Announcement
I-Mab announced the presentation of positive Phase 1b combination data for givastomig, in combination with nivolumab and mFOLFOX6, at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) in Barcelona (abstract #388MO).
AI Summary
I-Mab announced positive Phase 1b combination data for its bispecific antibody givastomig when administered with nivolumab and mFOLFOX6. The encouraging results were shared at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 in Barcelona (abstract #388MO). In the study, patients with Claudin 18.2-positive gastric cancers received the combination treatment as first-line therapy, and the data showed an objective response rate of 83% at the selected dose levels. Notably, responses were seen even in patients with low levels of PD-L1 and Claudin 18.2, highlighting the treatment’s potential across a wider patient population. The regimen was well tolerated overall, with only a few severe side effects reported. These findings support the continued clinical development of givastomig and strengthen its potential role in improving outcomes for patients with gastric cancer.
Read Announcement- Drug:
- Givastomig
- Announced Date:
- June 26, 2025
- Indication:
- In patients with advanced cancers
Announcement
I-Mab announced publication of ESMO Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) abstract #388MO related to positive data from a Phase 1b study evaluating givastomig in combination with nivolumab and mFOLFOX6 chemotherapy for metastatic gastric cancers.
AI Summary
I-Mab, a U.S.-based biotech company, announced the publication of abstract #388MO at the ESMO Gastrointestinal Cancers Congress 2025. The abstract detailed positive findings from a Phase 1b study that evaluated the use of givastomig combined with nivolumab and mFOLFOX6 chemotherapy for metastatic gastric cancers. In this study, an overall 71% objective response rate was observed, with an even higher response rate of 83% among patients treated at the selected dose levels for expansion. The treatment produced rapid and deep responses over time and was effective even in patients with low levels of PD-L1 and CLDN18.2 expression. Additionally, givastomig demonstrated a favorable safety profile with few serious gastrointestinal or liver-related side effects. These encouraging results support the potential of givastomig as part of a novel immunochemotherapy approach in the metastatic treatment setting.
Read Announcement- Drug:
- Givastomig
- Announced Date:
- June 18, 2025
- Estimated Event Date Range:
- July 2, 2025 - July 2, 2025
- Target Action Date:
- July 02, 2025
- Indication:
- In patients with advanced cancers
Announcement
I-Mab announced that Event to follow presentation of new Phase 1b combination dose escalation data for givastomig (Claudin 18.2 x 4-1BB bispecific antibody) at ESMO GI on July 2, 2025
AI Summary
I-Mab announced an upcoming webinar event on July 8, 2025, at 2:00pm EDT to recap key data from its recent Phase 1b combination dose escalation study for givastomig. Givastomig, a promising Claudin 18.2 x 4-1BB bispecific antibody, is being evaluated for its potential to treat Claudin 18.2-positive metastatic gastric cancers. The data, presented on July 2, 2025, at ESMO GI 2025 in a Mini Oral session, focuses on the safety and efficacy of givastomig when used in combination with nivolumab and chemotherapy. During the webinar, distinguished expert Dr. Samuel J. Klempner will review the study results and discuss their implications in combination immunochemotherapy. A live question and answer session will follow the presentation, with a replay available on the I-Mab website for 90 days, allowing stakeholders to gain further insights into this innovative therapeutic approach.
Read Announcement- Drug:
- Givastomig
- Announced Date:
- June 18, 2025
- Estimated Event Date Range:
- July 8, 2025 - July 8, 2025
- Target Action Date:
- July 08, 2025
- Indication:
- In patients with advanced cancers
Announcement
I-Mab announced that it will host a webinar to recap new givastomig data being presented at ESMO GI 2025, with a key opinion leader (KOL), on Tuesday, July 8, 2025 at 2:00pm EDT.
AI Summary
I-Mab, a global U.S.-based biotech company, has announced a webinar on Tuesday, July 8, 2025, at 2:00 pm EDT to review new givastomig data from ESMO GI 2025. During the webinar, a key opinion leader, Dr. Samuel J. Klempner, Associate Professor of Medicine at Massachusetts General Hospital, will discuss the promising Phase 1b dose escalation results for givastomig when combined with immunochemotherapy for Claudin 18.2-positive, metastatic gastric cancers. The presentation follows the live data session at ESMO GI, where Phase 1b safety and efficacy results for the bispecific antibody were initially shared. The webinar will include a live question and answer segment to provide further clarity on the findings, and a replay will be available on the I-Mab website for 90 days. This event offers an in-depth look at the recent developments for givastomig in the fight against gastric cancer.
Read Announcement- Drug:
- Givastomig
- Announced Date:
- March 7, 2025
- Indication:
- In patients with advanced cancers
Announcement
I-Mab announced that enrollment has been completed ahead of schedule in the first dose expansion cohort in the Phase 1b givastomig combination study, with continued momentum in the second dose expansion cohort.
AI Summary
I-Mab announced a significant milestone in its Phase 1b givastomig combination study for gastric cancer. Enrollment for the first dose expansion cohort was completed ahead of schedule, marking a strong early achievement in the clinical program. The study focuses on evaluating givastomig, a bispecific antibody that targets CLDN18.2-positive tumor cells by activating T cells through the 4-1BB pathway. This novel treatment is being studied in combination with standard therapies to determine the optimal dosing regimen for first-line gastric cancer treatment.
Momentum continues as the study progresses, with the first patient already dosed in the second expansion cohort. The company anticipates topline results from the 40-patient dose expansion study in the first half of 2026 and expects dose escalation data by the second half of 2025. These developments highlight I-Mab’s commitment to advancing precision immuno-oncology therapies.
Read Announcement- Drug:
- Givastomig
- Announced Date:
- March 7, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- In patients with advanced cancers
Announcement
I-Mab announced that Phase 1b dose escalation data expected to be presented in 2H 2025
AI Summary
I-Mab recently announced encouraging progress in its Phase 1b givastomig combination study for treating first-line gastric cancer. The study uses a novel CLDN18.2 x 4-1BB bispecific antibody to target tumor cells and improve treatment outcomes. Enrollment in the first dose expansion cohort was completed ahead of schedule, showing strong momentum in the trial.
Importantly, I-Mab stated that Phase 1b dose escalation data is expected to be presented in the second half of 2025. This upcoming data presentation could be key to establishing the optimal dosing regimen and demonstrating the potential benefits of givastomig in combination with standard care. The continued progress in patient recruitment and study milestones highlights the company’s commitment to advancing new treatment options for gastric cancer.
Read Announcement- Drug:
- Givastomig
- Announced Date:
- September 16, 2024
- Indication:
- In patients with advanced cancers
Announcement
I-Mab announced a poster presentation highlighting encouraging top-line results from its ongoing Phase 1 clinical study (NCT04900818) of givastomig, a novel first-in-class/ Claudin18.2 (CLDN18.2) and 4-1BB bispecific antibody immunostimulant, in patients with advanced cancers, especially gastric cancers (including gastroesophageal carcinoma, or GEC) at the European Society for Medical Oncology (ESMO) Congress 2024, taking place in Barcelona, Spain.
AI Summary
I-Mab has shared encouraging top-line results from its ongoing Phase 1 clinical study (NCT04900818) of givastomig at the ESMO Congress 2024 in Barcelona. Givastomig is a novel first-in-class bispecific antibody immunostimulant that targets Claudin 18.2-positive tumor cells and conditionally activates the 4-1BB pathway in the tumor microenvironment. The poster presentation highlighted the promising activity of givastomig as a single agent in patients with advanced cancers, particularly gastric cancers, including gastroesophageal carcinoma (GEC).
In the study, patients who had received multiple prior treatments demonstrated encouraging response rates, with a partial response observed in approximately 16% of cases and a disease control rate nearing 49%. The treatment was well tolerated at doses up to 18 mg/kg, with no dose-limiting toxicities, further supporting givastomig’s potential as a differentiated therapy for gastric cancers.
Read Announcement
TJ-CD4B FDA Regulatory Events
TJ-CD4B is a drug developed by I-Mab for the following indication: Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TJ-CD4B
- Announced Date:
- June 5, 2024
- Indication:
- Solid Tumors
Announcement
I-Mab announced that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE:BMY). The collaboration will evaluate the combination of givastomig, an investigational Claudin 18.2 x 4-1BB bispecific antibody jointly developed by I-Mab and ABL Bio (KOSDAQ: 298380), with Bristol Myers Squibb's immune checkpoint inhibitor, nivolumab, and chemotherapy (FOLFOX or CAPOX), as a potential first-line treatment for patients with advanced Claudin 18.2-positive gastric and esophageal cancers.
AI Summary
I-Mab has entered a clinical trial collaboration and supply agreement with Bristol Myers Squibb to study a new treatment for advanced gastric and esophageal cancers. The study will evaluate givastomig, an investigational Claudin 18.2 x 4-1BB bispecific antibody jointly developed by I-Mab and ABL Bio, in combination with Bristol Myers Squibb’s immune checkpoint inhibitor nivolumab and chemotherapy (FOLFOX or CAPOX). This triple-therapy approach aims to offer a potential first-line treatment for patients whose tumors test positive for Claudin 18.2. Early research on givastomig has shown promising safety and anti-tumor activity, and researchers are hopeful that combining it with nivolumab and chemotherapy will further enhance T-cell responses against tumors. The multinational Phase 1 study led by I-Mab will focus on assessing the safety and effectiveness of this innovative treatment regimen.
Read Announcement
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