A Study of DS-1471a In Subjects With Advanced Solid Tumors

Daiichi Sankyo

Status and phase

Terminated

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: DS-1471a

Study type

Interventional

Funder types

Industry

Identifiers

NCT06074705

DS1471-079

2024-517984-21-00 (EU Trial (CTIS) Number)

jRCT2031230234 (Other Identifier)

Details and patient eligibility

About

This first-in-human (FIH) study will assess the safety, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of DS-1471a in participants with advanced or metastatic solid tumors.

Full description

The objectives of this multinational, multicenter, open-label, 2-part, dose-escalation and dose-expansion, FIH study of participants with locally advanced or metastatic solid tumors are to evaluate the safety, maximum tolerated dose (MTD), recommended dose for expansion phase, preliminary efficacy, PK, and immunogenicity of DS-1471a.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

The clinical site will screen for the full inclusion criteria per protocol.

Sign and date the informed consent form (ICF)
Adults ≥18 years at the time the ICF is signed
Has a histologically or cytologically documented, locally advanced, metastatic, or unresectable solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
Has at least 1 measurable lesion according to RECIST v1.1 1 on computed tomography (CT) or magnetic resonance imaging (MRI)
Is willing and able to provide tumor tissue (newly obtained or archived)
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Life expectancy ≥3 months
Has a left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to Cycle 1 Day 1
Required baseline local laboratory data (within 7 days prior to Cycle 1 Day 1) as prespecified in the protocol
A female participant of childbearing potential is eligible to participate if the following conditions are met:
- Not pregnant as confirmed by highly sensitive pregnancy test within 7 days prior to study drug administration (Cycle 1 Day 1)
- Agrees to adhere to a highly effective contraceptive method and agrees not to donate eggs or freeze/store eggs, during the intervention period, and for 7 months following the last dose of study drug
A male participant is eligible to participate if he agrees to the following during the intervention period and for 4 months following the last dose of study drug:
- Avoid donating sperm
- Adhere to either abstinence or use of a condom during intercourse with a nonparticipant of childbearing potential PLUS partner use of an additional contraceptive method
Is willing and able to comply with scheduled visits, study drug administration plan, laboratory tests, other study procedures, and study restrictions
Patients with liver cirrhosis and liver cancer may be eligible to participate if they meet additional protocol specified criteria

Key Exclusion Criteria:

The clinical site will screen for the full exclusion criteria per protocol.

Has an inadequate treatment washout period prior to start of study treatment (Cycle 1 Day 1) as prespecified in the protocol
Has history of or current presence of untreated central nervous system (CNS) metastases
Has a history of leptomeningeal carcinomatosis
Has a history of (non-infectious) interstitial lung disease (ILD) other than radiation pneumonitis, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, arterial thromboembolic event, or pulmonary embolism
Has uncontrolled or clinically significant cardiovascular disease
Is requiring chronic steroid treatment (>10 mg daily prednisone equivalents)
Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial cancer in the gastrointestinal tract curatively resected by endoscopic surgery, or any other solid tumors curatively treated with no evidence of recurrent disease for ≥3 years
Has unresolved toxicities from previous anticancer treatment
Exposure to another investigational medical product within 4 weeks prior to Cycle 1 Day 1 or current participation in other therapeutic investigational procedures
Has an active, known, or suspected autoimmune disease
Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
Has an active hepatitis or uncontrolled hepatitis B or C infection, except for participants with hepatitis B infection that is controlled by antiviral therapy
For the Dose Escalation phase, has human immunodeficiency virus (HIV) infection. For the Dose Expansion phase, has active or uncontrolled HIV infection with exceptions per protocol.
Has received a live, attenuated vaccine (messenger RNA [mRNA] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug (Cycle 1 Day 1)
Female who is pregnant or breastfeeding or intends to become pregnant during the study
Has psychological, social, familial, or geographical factors that would prevent regular follow-up
Has prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

17 participants in 9 patient groups

Part 1, Dose Escalation Cohort 1: DS-1471a

Experimental group

Description: