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NCT04389632 (sigvotatug vedotin pembrolizumab cisplatin… in Carcinoma Non-Small Cell Lung Squamous Cell…): BVCT ex-ante prediction vs. reported outcome

On 15 Apr 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 23 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially numerically superior to anti-TROP2 ADC.

Clinical Trial

NCTID
NCT04389632
Drug Name
sigvotatug vedotin (SGN-B6A) pembrolizumab cisplatin carboplatin
Drug MoA
anti-alphavbeta6 integrin ADC that delivers MMAE as payload
Drug Modality
antibody-drug conjugate (ADC)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Carcinoma Non-Small Cell Lung Squamous Cell Carcinoma of Head and Neck HER2 Negative Breast Neoplasms Esophageal Squamous Cell Carcinoma Esophageal Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Ovarian Neoplasms Cutaneous Squamous Cell Cancer Exocrine Pancreatic Adenocarcinoma Urinary Bladder Neoplasms Uterine Cervical Neoplasms Stomach Neoplasms
Human Patients
824
Sponsor
Pfizer
Phase
Phase 1

Prediction of , index 993

Prospective Prediction
Prediction Index
993
Prediction Date
Commercial Prediction
SUCCESS (superior to anti-TROP2 ADC)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
404 days in advance
Readout Data Interpretation
20% ORR NSCLC and 3.5 months PFS and 13% TEAE discontinuation (vs 17% ORR for Trodelvy Heist et al. Camidge 2017 J Clinical Onco).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially numerically superior to anti-TROP2 ADC
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors
Phase
Phase 1
Status
Recruiting
Enrollment
1006
Lead sponsor
Seagen, a wholly owned subsidiary of Pfizer
Conditions
Carcinoma, Non-Small Cell Lung; Squamous Cell Carcinoma of Head and Neck; HER2 Negative Breast Neoplasms; Esophageal Squamous Cell Carcinoma; Esophageal Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Ovarian Neoplasms; Cutaneous Squamous Cell Cancer; Exocrine Pancreatic Adenocarcinoma; Urinary Bladder Neoplasms; Uterine Cervical Neoplasms; Stomach Neoplasms
Interventions
DRUG: sigvotatug vedotin; DRUG: pembrolizumab; DRUG: cisplatin; DRUG: carboplatin
Design
Sequential · None
Primary purpose
Treatment
Start
2020-06-08
Primary completion
2027-06-16
Completion
2029-03-22
Primary outcomes
  • Number of participants with adverse events (AEs) (Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 3 years)
  • Number of patients with laboratory abnormalities (Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years)
  • Number of participants with dose-limiting toxicities (DLTs) (Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years)

NCT04389632 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials