FDA Type B Meeting Appears Successful for Givastomig in Gastric Cancers

Developers recently announced a productive Type B meeting with the FDA, securing regulatory alignment with the agency on givastomig’s potential eligibility and pathway to accelerated approval for patients with first-line HER2-negative, Claudin (CLDN) 18.2–positive, PD-L1–positive gastroesophageal cancer.¹

Notably, they intend to initiate a registrational phase 3 trial for givastomig in combination with chemoimmunotherapy, with the earliest time frame hoped to be the fourth quarter of 2026; finalized study design plans will be created with the FDA’s assistance.

These benchmarks come following positive results from an ongoing phase 1b trial (NCT04900818) evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of givastomig, in several combinations, as treatment for patients with advanced or metastatic solid tumors.

“We are thrilled to receive the positive feedback from FDA confirming givastomig’s eligibility for an accelerated approval pathway,” stated Phillip Dennis, MD, PhD, chief medical officer of NovaBridge, in the press release.¹ “This important regulatory milestone builds on compelling phase 1b givastomig results that showed robust efficacy and favorable overall tolerability, with marked improvement relative to historical benchmarks for the standard of care in cross trial comparisons. Givastomig has the potential to be a first-in-class and best-in-class [CLDN] 18.2 therapeutic for gastric cancer in combination with immunochemotherapy. We are looking forward to continuing our discussions with FDA and to bringing givastomig to patients as quickly as possible.”

Is givastomig effective in gastroesophageal cancer?

Among 52 evaluable patients in the trial who were dosed at 8 mg/kg every 2 weeks and 12 mg/kg every 2 weeks, the updated results demonstrated a 75% objective response rate (ORR) across the evaluable population. Specifically, patients receiving the 8 mg/kg dose achieved a 77% ORR, while those in the 12 mg/kg cohort reached a 73% ORR. Responses were observed across a wide range of PD-L1 and CLDN 18.2 expression levels.

In addition to the high response rates, the combination regimen showed promising durability. With 53 evaluable patients, the median progression-free survival (PFS) was reported to be 16.9 months, with an 82% landmark PFS rate at 6 months.

How was this phase 1b givastomig trial designed?

The study is a multi-center, open-label, dose-escalation and dose-expansion trial.² The study is structured into 4 distinct parts to assess both monotherapy and combination regimens. Part 1 focused on monotherapy dose escalation in patients with advanced or metastatic solid tumors whose disease had progressed despite standard therapy. The subsequent parts evaluated givastomig in combination with standard-of-care therapies: part 2 targeted treatment-naïve metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma; part 3 focused on pancreatic adenocarcinoma; and part 4 involved biliary tract cancer.

The dosing schedule for the monotherapy arm included levels ranging from 0.1 mg/kg to 15 mg/kg administered biweekly plus an 18 mg/kg dose administered every 3 weeks. For the combination cohorts, givastomig was administered alongside nivolumab (Opdivo) and chemotherapy.

To be eligible for the combination portion, patients must have had histologically confirmed metastatic adenocarcinoma, HER2-negative status, and CLDN 18.2 positivity. Patients must also have had an ECOG performance status of 0 or 1 and known PD-L1 status with prior testing by immunohistochemistry.

Notable exclusion criteria included prior exposure to CLDN 18.2–targeted therapies or 4-1BB agonists, active autoimmune disease requiring systemic treatment, and unstable digestive tract bleeding within 6 weeks of study entry.

How safe is givastomig?

Safety results from the phase 1b portion indicated that the combination of givastomig and immunochemotherapy was well tolerated. The study reported a favorable overall safety profile with no evidence of dose-dependent toxicity at the therapeutic levels being advanced into further testing.

References

1. NovaBridge announces productive FDA type B meeting on potential accelerated approval pathway for givastomig in gastric cancer. News release. NovaBridge Biosciences. Published March 16, 2026. Accessed March 17, 2026. https://tinyurl.com/4ejd978s
2. Study of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors. ClinicalTrials.gov. Updated March 5, 2026. Accessed March 17, 2026. https://tinyurl.com/yckam7kb