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
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "Incidence and severity of serious adverse events and adverse events (all Parts)" | — |
Secondary
| Measure | Time 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