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

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)

About Us | OrionPharma

ODM-209

NCT03878823

I/II

Poster Session-466

ODM-209, a CYP11A1 inhibitor in patients with mCRPC: Results from the STESIDES phase 1 study.


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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

Elicio Therapeutics Announces $7.0 Million Private

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.

 

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Executive Summary

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

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