NCT03957915: INA03

Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

Completed EARLY_PHASE1 Last updated 6 August 2025

What this trial tests

EARLY_PHASE1 trial testing INA03 administration in Acute Lymphoblastic Leukemia Recurrent in 33 participants. Completed in 24 February 2025.

Timeline

29 May 2020

Primary endpoint
15 July 2024

24 February 2025

Quick facts

Lead sponsor	Institut Paoli-Calmettes
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	29 May 2020
Primary completion	15 July 2024
Estimated completion	24 February 2025
Sites	3 locations across France

Drugs / interventions tested

• INA03 administration — full drug profile →

Conditions studied

• Acute Lymphoblastic Leukemia Recurrent — all drugs for Acute Lymphoblastic Leukemia Recurrent →
• Acute Lymphoblastic Leukemia, in Relapse — all drugs for Acute Lymphoblastic Leukemia, in Relapse →
• Acute Myeloid Leukemia, in Relapse — all drugs for Acute Myeloid Leukemia, in Relapse →
• Acute Myeloid Leukaemia Recurrent — all drugs for Acute Myeloid Leukaemia Recurrent →

Sponsor

Institut Paoli-Calmettes — full company profile →

Who can join

18 and older, any sex, with Acute Lymphoblastic Leukemia Recurrent or Acute Lymphoblastic Leukemia, in Relapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL.

The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Evolving Landscape of Antibody-Drug Conjugates: In Depth Analysis of Recent Research Progress.
   Sasso JM, Tenchov R, Bird R, Iyer KA, et al · · 2023 · cited 89× · PMID 37821099 · DOI 10.1021/acs.bioconjchem.3c00374
2. Antibody Therapies for Acute Myeloid Leukemia: Unconjugated, Toxin-Conjugated, Radio-Conjugated and Multivalent Formats.
   Williams BA, Law A, Hunyadkurti J, Desilets S, et al · · 2019 · cited 43× · PMID 31434267 · DOI 10.3390/jcm8081261
3. Antibody drug conjugates in the clinic.
   Udofa E, Sankholkar D, Mitragotri S, Zhao Z. · · 2024 · cited 12× · PMID 39545074 · DOI 10.1002/btm2.10677
4. Present and Future Role of Immune Targets in Acute Myeloid Leukemia.
   Damiani D, Tiribelli M. · · 2022 · cited 12× · PMID 36612249 · DOI 10.3390/cancers15010253
5. The Immunotherapy of Acute Myeloid Leukemia: A Clinical Point of View.
   Mosna F. · · 2024 · cited 9× · PMID 39001421 · DOI 10.3390/cancers16132359
6. Transferrin Receptor Overexpression in Solid Tumors Is Associated with Inflamed Microenvironments and Upregulated Immune Checkpoints, with Implications for Immunotherapy Sensitivity.
   Trabolsi A, Lekakis M, Commisso PM, Gandhi N, et al · · 2026 · PMID 42122198 · DOI 10.3390/cancers18091402
7. Targeting tumor dormancy: the next frontier in gastrointestinal stromal tumor therapy.
   Wu S, Liu H, Yin Y, Li J, et al · · 2026 · PMID 41955967 · DOI 10.1016/j.neo.2026.101306
8. P548: PRELIMINARY RESULTS OF A PHASE 1, FIRST-IN-HUMAN STUDY OF INA03, AN ANTI-CD71 ANTIBODY-DRUG CONJUGATE IN PATIENTS WITH RELAPSED OR REFRACTORY (R/R) ACUTE LEUKEMIAS
   Garciaz S, Bories P, Lopez Almeida L, Boher J, et al · · 2023