Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies

Conditions

Cancer

Brief summary

All Parts: Incidence and severity of serious adverse events and adverse events, Parts 1 and 2 Dose Escalation Cohorts: Incidence of dose limiting toxicities (DLTs), Part 3 Neoadjuvant Cohorts (Cohorts 3c and 3d): Pathologic complete response (pCR) per local assessment for pathology review

Detailed description

Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) − Objective response rate (ORR) by RECIST 1.1, duration of response (DoR) and TTR (time to response) per independent central review (ICR)., Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) - ORR by RECIST 1.1, DoR and TTR per investigator assessment, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) − ORR for overall tumor burden, injected and noninjected lesions by itRECIST, DoR, and TTR per investigator assessment, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) - Progression free survival (PFS) by RECIST 1.1 per ICR, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) - PFS by RECIST 1.1 per investigator assessment, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) - Overall survival (OS), Part 3 Neoadjuvant Cohorts (Cohorts 3c and 3d) − pCR per central assessment for pathology review, Part 3 Neoadjuvant Cohorts (Cohorts 3c and 3d) − Major pathologic response (MPR) per local assessment for pathology review, Part 3 Neoadjuvant Cohorts (Cohorts 3c and 3d) − MPR per central assessment for pathology review, Part 3 Neoadjuvant Cohorts (Cohorts 3c and 3d) − Event free survival (EFS) by RECIST 1.1 per investigator assessment, Part 3 Neoadjuvant Cohorts (Cohorts 3c and 3d) - OS, TransCon TLR7/8 Agonist PK parameters

Related papers

No related papers found yet.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGTransCon TLR7/8 Agonist

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
All Parts: Incidence and severity of serious adverse events and adverse events, Parts 1 and 2 Dose Escalation Cohorts: Incidence of dose limiting toxicities (DLTs), Part 3 Neoadjuvant Cohorts (Cohorts 3c and 3d): Pathologic complete response (pCR) per local assessment for pathology review	—

Secondary

Measure	Time frame
Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) − Objective response rate (ORR) by RECIST 1.1, duration of response (DoR) and TTR (time to response) per independent central review (ICR)., Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) - ORR by RECIST 1.1, DoR and TTR per investigator assessment, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) − ORR for overall tumor burden, injected and noninjected lesions by itRECIST, DoR, and TTR per investigator assessment, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) - Progression free survival (PFS) by RECIST 1.1 per ICR, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) - PFS by RECIST 1.1 per investigator assessment, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3	—

Measure

Time frame

Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) − Objective response rate (ORR) by RECIST 1.1, duration of response (DoR) and TTR (time to response) per independent central review (ICR)., Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) - ORR by RECIST 1.1, DoR and TTR per investigator assessment, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) − ORR for overall tumor burden, injected and noninjected lesions by itRECIST, DoR, and TTR per investigator assessment, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) - Progression free survival (PFS) by RECIST 1.1 per ICR, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3a and 3b) - PFS by RECIST 1.1 per investigator assessment, Parts 1 and 2, and Part 3 HNSCC and other HPV-associated tumor types Cohorts (Cohorts 3

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Countries

Netherlands, Spain

Outcome results

None listed