NCT05011188

FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer

Active, enrolled Phase 1, PHASE2 Last updated 27 August 2025

What this trial tests

Phase 1, PHASE2 trial testing FOR46 in Metastatic Castration-resistant Prostate Cancer in 44 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 January 2022

Primary endpoint
31 July 2027

31 July 2027

Quick facts

Lead sponsor	Rahul Aggarwal
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	19 January 2022
Primary completion	31 July 2027
Estimated completion	31 July 2027
Sites	1 location across United States

Drugs / interventions tested

• FOR46 — full drug profile →
• Enzalutamide (enzalutamide) — full drug profile →
• Pegfilgrastim (PEGFILGRASTIM) — full drug profile →
• Blood Samples — full drug profile →

Conditions studied

• Metastatic Castration-resistant Prostate Cancer — all drugs for Metastatic Castration-resistant Prostate Cancer →
• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Rahul Aggarwal — full company profile →

Who can join

18 and older, male only, with Metastatic Castration-resistant Prostate Cancer or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1b/2 study evaluating FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on abiraterone. FOR46 is designed to target and bind to CD46, a transmembrane cellular protein expressed at moderate or high levels in numerous cancer types. The investigators hypothesize that the combination of FOR46 plus enzalutamide will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients.

Publications & conference data

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

1. Marine Natural Products in Clinical Use.
   Haque N, Parveen S, Tang T, Wei J, et al · · 2022 · cited 101× · PMID 36005531 · DOI 10.3390/md20080528
2. 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
3. Treatment of Prostate Cancer with CD46-targeted 225Ac Alpha Particle Radioimmunotherapy.
   Bidkar AP, Wang S, Bobba KN, Chan E, et al · · 2023 · cited 34× · PMID 36917693 · DOI 10.1158/1078-0432.ccr-22-3291
4. CD46 targeted <sup>212</sup>Pb alpha particle radioimmunotherapy for prostate cancer treatment.
   Li J, Huang T, Hua J, Wang Q, et al · · 2023 · cited 28× · PMID 36906664 · DOI 10.1186/s13046-023-02636-x
5. Phase I, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients With Metastatic Castration-Resistant Prostate Cancer.
   Aggarwal RR, Vuky J, VanderWeele D, Rettig M, et al · · 2025 · cited 13× · PMID 40138611 · DOI 10.1200/jco-24-01989
6. Overcoming drug resistance in castrate-resistant prostate cancer: current mechanisms and emerging therapeutic approaches.
   Khorasanchi A, Hong F, Yang Y, Singer EA, et al · · 2025 · cited 12× · PMID 40051495 · DOI 10.20517/cdr.2024.173
7. Current Status of Radiolabeled Monoclonal Antibodies Targeting PSMA for Imaging and Therapy.
   Abusalem M, Martiniova L, Soebianto S, DePalatis L, et al · · 2023 · cited 12× · PMID 37760506 · DOI 10.3390/cancers15184537
8. Advancements in antibody-drug conjugates as cancer therapeutics.
   Fong JY, Phuna Z, Chong DY, Heryanto CM, et al · · 2025 · cited 11× · PMID 40814440 · DOI 10.1016/j.jncc.2025.01.007