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A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors

Study acronym: CHANCES
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised
    v6
  2. Primary completion date: Mar 2025 to Mar 2027
    • Study completion date: Feb 2026 to Mar 2027
    • Eligibility criteria expanded, about 141 words
    v5
  3. Primary completion date: Mar 2024 to Mar 2025
    • Study completion date: Feb 2025 to Feb 2026
    v4
  4. Primary completion date: Jul 2023 to Mar 2024
    • Study completion date: Jul 2024 to Feb 2025
    • Start date: Jan 26, 2022 to Jan 21, 2022
    • Site contact updated
    v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jun 2023 to Jul 2023
    • Study completion date: Jun 2024 to Jul 2024
    • Start date changed from estimate of Nov 29, 2021 to Jan 26, 2022
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Institut Paoli-Calmettes
78 trials monitored
See 1 trial at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Pancreatic Cancer
1,739 trials monitored
See 106 trials at risk
and 4 more diseases
CHANCES-IPC 2021-008 is First In Human, Phase I, multicenter, European study evaluating an anti-CD73, IPH5301 in advanced and/or metastatic cancer. The trial will be conducted in two parts, Part I- Dose escalation: This part aims to identify the maximum tolerated dose (MTD) of IPH5301 agent in monotherapy and recommended phase 2 dose (RP2D) for future trials, followed by a safety expansion study part cohort. Part II- Expansion cohort: A total of 12 HER2-expressing breast cancer patients is planned to be enrolled into the next expansion cohort to select a recommended dose of IPH5301 to be administered in combination with chemotherapy and trastuzumab for evaluation in future trials with selected advanced solid tumors.
Trial Details
NCT Number NCT05143970
Lead Sponsor Institut Paoli-Calmettes
Collaborators: Innate Pharma
Conditions
(from sponsor)		 Metastatic Cancer, Metastatic Breast Cancer, Metastatic Pancreatic Cancer, Metastatic Gastric Cancer, Metastatic Lung Cancer, Metastatic Ovary Cancer, Oesophageal Cancer, Endometrial Cancer +1 more
Related terms Breast Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Lung Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov