First-of-its-kind Human Trial | ASCO 2024 Preview

First‐in‐human (FIH) trials serve as the link to advance new promising drug candidates and are conducted primarily to determine the safe dose range for further clinical development. There are multiple players actively participating to discuss their first-in-human trial data readouts, this data looks extremely interesting in terms of the novel class of therapies that are being developed in the pipeline, for example,

We already know about the well-established CDK4/6 inhibitors in HR+/HER2- Breast Cancer, but now we have the first data for CDK4 inhibitors in the same patient segment.
The colorectal cancer market is more about EGFRs and FOLFOX/FOLFIRI with not much dependency on PD-1/PD-L1s, we look forward to what the PD-1/1L-2 bispecific antibody fusion protein has in store for colorectal and melanoma.
Another new class to look forward is anti-CEACAM Antibody Drug Conjugate in Colorectal Cancer
Metastatic Prostate Cancer patients heavily rely on androgen-deprivation therapy, radioligand therapy, and immunotherapy. Post strong uptake of Novartis’ radioligand therapy, we look forward to the data of a new class, CYP11A1 inhibitor in patients with mCRPC.

DelveInsight has compiled top abstracts from the ASCO 2024 Conference, showcasing first-in-class/first-in-human trials.

Company	Drug	Trial ID/ Acronym	Phase	Abstract ID	Abstract Title
	PF-07220060	NCT04557449	I/II	Poster Session - 253, Abstract- 3108	First-in-human phase 1/2a study of the first-in-class, next-generation CDK4-selective inhibitor PF-07220060 + endocrine therapy (ET): Updated safety data in patients with HR+/HER2− mBC
	IBI363	NCT05460767	Ia/Ib	Poster Session - 256, Abstract- 3593	First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients with advanced colorectal cancer: Safety and efficacy results from a phase I study
	IBI363	NCT05460767	I	Poster Session – 346, Abstract- 9562	First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients with advanced melanoma: Safety and efficacy results from a phase I study.
	M9140	NCT05464030	I	Oral Abstract Session - 3000	First-in-human trial of M9140, an anti-CEACAM5 antibody drug conjugate (ADC) with exatecan payload, in patients (pts) with metastatic colorectal cancer (mCRC)
	ODM-209	NCT03878823	I/II	Poster Session-466	ODM-209, a CYP11A1 inhibitor in patients with mCRPC: Results from the STESIDES phase 1 study.
$C:\Users\Himanshu Saxena\AppData\Local\Packages\Microsoft.Windows.Photos_8wekyb3d8bbwe\TempState\ShareServiceTempFolder\download.jpeg$	ABBV-400	NCT05029882	I	Rapid Oral Abstract Session - 3515	First-in-human study of ABBV-400, a novel c-Met–targeting antibody-drug conjugate, in advanced solid tumors: Results in colorectal cancer
	KSQ-4279 (RO7623066)	NCT05240898	I	Oral Abstract Session - 3005	First-in-human phase I trial of the oral first-in-class ubiquitin specific peptidase 1 (USP1) inhibitor KSQ-4279 (KSQi), given as single agent (SA) and in combination with olaparib (OLA) or carboplatin (CARBO) in patients (pts) with advanced solid tumors, enriched for deleterious homologous recombination repair (HRR) mutations
	Nadunolimab	NCT05653752	I	Poster Session - 256, Abstract- 3593	YL202/BNT326, a HER3-targeted ADC, in patients with locally advanced or metastatic non-small cell lung cancer and breast cancer: Preliminary results from a first-in-human phase I trial
	ELI-002	NCT05726864	I	Poster Session- 115	AMPLIFY-7P, a first-in-human safety and efficacy trial of adjuvant mKRAS-specific lymph node targeted amphiphile ELI-002 7P vaccine in patients with MRD–positive pancreatic and colorectal cancer.

Tags:

ASC0 2024 Spotlight: Unveiling First-of-its-kind Human Trial Abstracts!

First-of-its-kind Human Trial | ASCO 2024 Preview

Executive Summary

Recent Articles