# A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

> **NCT04682431** · PHASE1 · TERMINATED · sponsor: **Ikena Oncology** · enrollment: 127 (actual)

## Conditions studied

- Advanced Solid Tumor
- Gynecologic Cancer
- Breast Cancer
- Colorectal Cancer
- Gastric Adenocarcinoma
- Lung Adenocarcinoma
- Pancreatic Cancer
- Head and Neck Cancer

## Interventions

- **DRUG:** PY159 Single agent dose level 1
- **DRUG:** PY159 Single agent dose level 2
- **DRUG:** PY159 Single agent dose level 3
- **DRUG:** PY159 Single agent dose level 4
- **DRUG:** PY159 Single agent dose level 5
- **DRUG:** PY159 Single agent dose level 6
- **DRUG:** PY159 Single agent dose level 7
- **DRUG:** PY159/Pembrolizumab Combination dose level 1
- **DRUG:** PY159/Pembrolizumab Combination dose level 2
- **DRUG:** PY159/Pembrolizumab Combination dose level 3
- **DRUG:** PY159/Pembrolizumab Combination dose level 4
- **DRUG:** PY159 Single agent dose expansion cohort
- **DRUG:** PY159/Pembrolizumab Combination dose expansion cohort 1
- **DRUG:** PY159/Pembrolizumab Combination dose expansion cohort 2
- **DRUG:** PY159/Pembrolizumab Combination dose expansion cohort 3
- **DRUG:** PY159/Pembrolizumab Combination dose expansion cohort 4
- **DRUG:** PY159/Pembrolizumab Combination dose expansion cohort 5
- **DRUG:** PY159/Pembrolizumab Combination dose expansion cohort 6

## Key facts

- **NCT ID:** NCT04682431
- **Lead sponsor:** Ikena Oncology
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-11-10
- **Primary completion:** 2023-08-25
- **Final completion:** 2023-08-31
- **Target enrollment:** 127 (ACTUAL)
- **Why stopped:** Sponsor business decision.
- **Last updated:** 2024-03-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04682431

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04682431, "A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT04682431. Licensed CC0.

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