Skip to content

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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509143-27-00
Acronym
ASND0029
Enrollment
120
Registered
2023-12-15
Start date
2023-11-27
Completion date
Unknown
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic solid tumor malignancies, platinum resistant ovarian cancer, post-anti-pd-1 melanoma, second line or later cervical cancer, neoadjuvant melanoma and neoadjuvant non-small cell lung cancer, post-anti-pd-L1 non-small cell lung cancer, post-anti-pd-L1 small cell lung cancer, second line or later HER2+ breast cancer

Brief summary

"Incidence and severity of serious adverse events and adverse events (all Parts)"

Detailed description

Parts 1 and 2; Part 3, Cohorts 3, 4, 5, 8, 9, 10, 11, 12, 13; and Part 4: • Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), duration of response (DoR), and time to response (TTR) per independent central review (ICR) • ORR by RECIST 1.1, DoR, and TTR per investigator assessment, Parts 1 and 2; Part 3, Cohorts 3, 4, 5, 8, 9, 10, 11, 12, 13; and Part 4: • Progression-free survival (PFS) by RECIST 1.1 per ICR • PFS by RECIST 1.1 per investigator assessment • Overall Survival (OS), Part 3 Neoadjuvant Cohorts (melanoma in Cohorts 6a-c, and non-small cell lung cancer in Cohort 7) • ORR prior to surgery by RECIST 1.1 per ICR • ORR prior to surgery by RECIST 1.1 per investigator assessment • Pathologic complete response (pCR) per central assessment for pathology review, Part 3 Neoadjuvant Cohorts (melanoma in Cohorts 6a-c, and non-small cell lung cancer in Cohort 7): • Major pathologic response (MPR) per central assessment for pathology review • pCR per local assessment for pathology review • MPR per local assessment for pathology review • Event-free survival (EFS) by RECIST 1.1 per ICR • EFS by RECIST 1.1 per investigator assessment • OS, TransCon IL-2 β/γ and Free IL-2 β/γ PK parameters, alone or in combination with pembrolizumab, or SOC chemotherapy, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy, or in combination with SOC trastuzumab or SOC trastuzumab emtansine (T-DM1)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Ascendis Pharma Oncology Division A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
"Incidence and severity of serious adverse events and adverse events (all Parts)"

Secondary

MeasureTime frame
Parts 1 and 2; Part 3, Cohorts 3, 4, 5, 8, 9, 10, 11, 12, 13; and Part 4: • Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), duration of response (DoR), and time to response (TTR) per independent central review (ICR) • ORR by RECIST 1.1, DoR, and TTR per investigator assessment, Parts 1 and 2; Part 3, Cohorts 3, 4, 5, 8, 9, 10, 11, 12, 13; and Part 4: • Progression-free survival (PFS) by RECIST 1.1 per ICR • PFS by RECIST 1.1 per investigator assessment • Overall Survival (OS), Part 3 Neoadjuvant Cohorts (melanoma in Cohorts 6a-c, and non-small cell lung cancer in Cohort 7) • ORR prior to surgery by RECIST 1.1 per ICR • ORR prior to surgery by RECIST 1.1 per investigator assessment • Pathologic complete response (pCR) per central assessment for pathology review, Part 3 Neoadjuvant Cohorts (melanoma in Cohorts 6a-c, and non-small cell lung cancer in Cohort 7): • Major pathologic response (MPR) per central assessment for pathology review • pCR p

Countries

Belgium, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026