BioinvestGPT

BioinvestGPT ApS · Research use only

NCT06228326 (KB707 in advanced non-small cell lung cancer): BVCT ex-ante prediction vs. reported outcome

On 31 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 18 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet weak (in ORR) and commercially probably insufficient (in ORR with OS data pending).

Clinical Trial

NCTID
NCT06228326
Acronym
KYANITE-1
Drug Name
KB707
Drug MoA
intratumorally injected HSV1-delivered IL2 and IL12
Drug Modality
gene therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
advanced non-small cell lung cancer (NSCLC)
Human Patients
140
Sponsor
Krystal Biotech
Phase
Phase 1 Phase 2

Prediction of , index 1708

Prospective Prediction
Prediction Index
1708
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS)
Technical Prediction
partial SUCCESS (statistically maybe significant clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
140 days in advance
Readout Data Interpretation
KB707 achieved 27% confirmed ORR (6/33) for any advanced NSCLC patients; non-superior to pembrolizumab + ipilimumab that achieved 20-30% confirmed ORR for EGFRwt advanced NSCLC patients (10.1016/j.lungcan.2018.12.015) and inferior to osimertinib that achieved 71% ORR for EGFRmut advanced NSCLC patients (10.1056/NEJMoa1612674); OS data pending
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet weak (in ORR) and commercially probably insufficient (in ORR with OS data pending)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
KB707-02: A Phase 1/2 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
250
Lead sponsor
Krystal Biotech, Inc.
Conditions
Lung Cancer, Non-small Cell; Lung Cancer Metastatic; Solid Tumor, Adult; Advanced Cancer; Lung Cancer (NSCLC)
Interventions
BIOLOGICAL: KB707; DRUG: Pembrolizumab (KEYTRUDA®); DRUG: Chemotherapy; DRUG: Docetaxel
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2024-04-17
Primary completion
2027-02
Completion
2028-07
Primary outcomes
  • To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE) (up to 36 months)

NCT06228326 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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