Corbus Pharmaceuticals Dosed First TEMPO-1 Trial Patient
The Phase 3 trial evaluates the efficacy of the CRB-701 antibody drug conjugate in patients with oropharyngeal cancer.
Updated on Sept. 29, 2026 in Cancer
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Corbus Pharmaceuticals has officially dosed the first patient in its TEMPO-1 study, a randomized controlled trial involving 250 participants. The study assesses CRB-701, a Nectin-4 targeted antibody drug conjugate, for the treatment of recurrent or metastatic head and neck cancers.
Why it matters
Patients suffering from recurrent or metastatic head and neck cancer currently face significant unmet treatment needs. This trial aims to secure the clinical evidence required for potential regulatory submission and eventual drug approval.
In prior phase 1/2 analysis, the 3.6 mg/kg dose of CRB-701 demonstrated a 42.9% confirmed objective response rate. Participants also exhibited a median duration of response of 6.3 months and a median progression-free survival of 5.6 months.
The players
Corbus Pharmaceuticals
Based in Norwood, Massachusetts, this clinical-stage company develops drug candidates for the treatment of cancer and inflammatory diseases.
Sarah Cannon Research Institute
Located in Orlando, Florida, this global oncology research organization specializes in conducting clinical trials for novel cancer therapies.
The details
The trial compares the efficacy of CRB-701 against standard investigator choice treatments including capecitabine, cetuximab, or docetaxel. The drug utilizes a site-specific, cleavable linker technology with a drug-to-antibody ratio of two to target cancerous cells.
Timeline
September 29, 2026: First patient dosed in TEMPO-1 study.
2026: ASCO Annual Meeting presentation of phase 1/2 data.
The Big Picture
This study follows the precedent set by the FDA Fast Track designation program, which prioritizes drugs for conditions where treatment options remain limited. The trial extends this regulatory framework by seeking data that could lead to accelerated approval for patients with unmet medical needs.
The TEMPO-1 trial offers potential new treatment pathways for patients currently dealing with recurrent or metastatic head and neck cancers. Participants benefit from access to a novel antibody drug conjugate that has previously demonstrated significant response rates in earlier clinical phases.
The takeaway
This trial represents a shift toward targeted antibody drug conjugates for treating head and neck cancers that have historically been difficult to manage. Patients should consult their oncologists to determine if they meet the eligibility criteria for enrollment in upcoming clinical sites.
Further reading
For more information on ongoing clinical research, visit the Cancer section.
Source note: This article includes information reported by The Manila times.
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