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NCT05081609 (TransCon IL-2 β/γ Pembrolizumab… in Solid Tumor Malignancies): BVCT ex-ante prediction vs. reported outcome

BVCT made 2 dated predictions for this trial. On 12 Apr 2023 it predicted technical success and commercial success; the 3 Jun 2024 readout is classified on the dashboard as True Negative (TN). On 29 Aug 2024 it predicted technical partial success and commercial partial success; the 13 Sep 2024 readout is classified on the dashboard as True Negative (TN).

Clinical Trial

NCTID
NCT05081609
Acronym
IL Believe
Drug Name
TransCon IL-2 β/γ Pembrolizumab Chemotherapy drug TransCon TLR7/8 Agonist Surgery
Drug MoA
IL-2 β/γ agonist
Drug Modality
protein prodrug
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Solid Tumor Malignancies
Human Patients
473
Sponsor
Ascendis Pharma
Phase
Phase 1 Phase 2

Prediction of , index 661

Prospective Prediction
Prediction Index
661
Prediction Date
Commercial Prediction
SUCCESS (mono); SUCCESS (combo + pembrolizumab); SUCCESS (combo + chemo); FAILURE (combo + TransCon TLR7/8)
Technical Prediction
SUCCESS (mono); SUCCESS (combo + pembrolizumab); SUCCESS (combo + chemo); FAILURE (combo + TransCon TLR7/8)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
418 days in advance
Readout Data Interpretation
40% ORR (IL2 + TLR7/8) for advanced melanoma (40-48% for BRAF-mutated BRAF/MEK inhibitors or 29% for BRAF-wild-type ipilimumab + pembrolizumab); 25% ORR (IL2) for colorectal cancer (vs 12-16.4% ORR for regorafenib + ICI or cetuximab + chemo); 100% ORR (IL2 + pembro) for SCLC (40% ORR for tarlatamab).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially partially insufficient (IL2 + TLR7/8) yet commercially partially sufficient (other arms)
Prediction Classification
True Negative (TN)

Prediction of , index 661

Prospective Prediction
Prediction Index
661
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient additive clinical benefit for TransCon IL2 for certain cancer subindications only); partial FAILURE (commercially insufficient clinical benefit for TransCon TLR7/8)
Technical Prediction
partial SUCCESS (statistically significant additive clinical benefit for TransCon IL2 for certain cancer subindications only); partial FAILURE (statistically insignificant clinical benefit for TransCon TLR7/8)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
15 days in advance
Readout Data Interpretation
TransCon IL-2 β/γ + chemotherapy achieved 11% cORR for PROC (2/18 including 4 discontinued patients); much lower than targeted therapy mirvetuximab soravtansine (32.4% ORR for FRalpha-expressing PROC).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant (very weak efficacy) and commercially TBD
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
320
Lead sponsor
Ascendis Pharma Oncology Division A/S
Conditions
Advanced Solid Tumor; Locally Advanced Solid Tumor; Metastatic Solid Tumor; Platinum-resistant Ovarian Cancer; Post Anti-PD-1 Melanoma; 2L+ Cervical Cancer; Neoadjuvant Melanoma; Neoadjuvant Non-Small Cell Lung Cancer; Post Anti-PD-(L)1 Non-Small Cell Lung Cancer; Post Anti-PD-(L)1 Small Cell Lung Cancer; Third Line or Later (3L+) HER2+ Breast Cancer; Second or Third Line (2L/3L) Cervical Cancer; Third-line or Later (3L+) Platinum-resistant Ovarian Cancer (PROC)
Interventions
DRUG: TransCon IL-2 β/γ; DRUG: Pembrolizumab; DRUG: Chemotherapy drug; DRUG: TransCon TLR7/8 Agonist; PROCEDURE: Surgery; DRUG: Trastuzumab; DRUG: Trastuzumab emtansine (T-DM1)
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-01-11
Primary completion
2027-08
Completion
2029-08
Primary outcomes
  • Safety and Tolerability (Through study completion, expected average of 2 years)
  • Maximum Tolerated Dose (MTD) (Each cycle is 21 days)
  • Recommended Phase 2 Dose (RP2D) (12 months)

NCT05081609 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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