A Study of DS-9606a in Patients With Advanced Solid Tumors

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Daiichi Sankyo

Status and phase

Enrolling
Phase 1

Conditions

Metastatic Cancer
Advanced Cancer
Germ Cell Tumor
Ovarian Cancer

Treatments

Drug: DS-9606a

Study type

Interventional

Funder types

Industry

Identifiers

NCT05394675
2022-000120-38 (EudraCT Number)
DS9606-137
REFMAL 823 (Other Identifier)

Details and patient eligibility

About

This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.

Full description

This first-in-human, phase 1 study will consist of 2 parts. In Part A (Dose Escalation), the primary objectives will be to investigate the safety and tolerability of DS-9606a in advanced solid tumors and to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE). In Part B (Dose Expansion), the safety and tolerability of DS-9606a will be further explored and the overall response rate will be assessed. The secondary objectives of the study will assess pharmacokinetic properties of DS-9606a and investigate the duration of response and progression-free survival of DS-9606a, and assess the immunogenicity of DS-9606a.

Enrollment

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • At least 18 years old at the time of written informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Availability of archived tumor tissue samples (mandatory); patients with germ cell tumors without archived tumor samples may be allowed with approval
  • Has a left ventricular ejection fraction (LVEF) ≥50% as determined by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before the start of study treatment
  • Adequate bone marrow and organ function within 7 days before the start of study treatment
  • Life expectancy ≥3 months
  • Adequate treatment washout period prior to start of study treatment
  • Male patients with female partners of childbearing potential and female patients of child-bearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for at least 4 months (for males) and for at least 7 months (for females) after the last dose of study drug. Males must agree not to freeze or donate sperm throughout the study period for at least 4 months after final administration of study drug. Females must agree not to donate or retrieve ova for own use throughout the study period and for at least 7 months after final study drug administration.

Dose Escalation Participants Only:

  • Histologically- or cytologically-documented locally advanced or metastatic cancers, including but not limited to: ovarian cancer (including fallopian tube and primary peritoneal carcinoma), germ cell tumors, uterine and endometrial cancers, pancreatic adenocarcinoma, non-squamous NSCLC, or gastric cancer
  • Disease progression with standard of care therapies for metastatic disease known to confer benefit, or are intolerant to or refuse standard treatment.

Dose Expansion Participants Only:

Consent to provide pre-treatment (mandatory) and on-treatment tissue biopsy sample (mandatory if not clinically contraindicated)

Histologically or cytologically-documented locally advanced or metastatic cancers including:

  • Cohort B-1: Ovarian cancer
  • Cohort B-2: Refractory germ cell tumors

Exclusion criteria

  • Has history or current presence of central nervous system metastases, except for participants who have completed radiotherapy or surgery ≥4 weeks before the start of treatment, and fulfill all criteria (no evidence of disease progression in the CNS and no requirement for chronic corticosteroids) within 2 weeks before the start of treatment
  • Other invasive malignancy within 2 years; prior or concurrent non-invasive malignancies and/or patients with localized malignancies that were treated with curative intent who remain disease-free and are considered low likelihood for recurrence may be enrolled
  • History of myocardial infarction or unstable angina within 6 months before study treatment
  • Has a history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment
  • Has a corrected QT interval by Fridericia's formula (QTcF), of >470 ms based on the average of triplicate 12-lead electrocardiogram (ECG) per local read
  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Has an uncontrolled infection requiring ongoing or long-term therapy
  • Has a known active hepatitis or uncontrolled hepatitis B or C infection

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

125 participants in 3 patient groups

Dose Escalation: DS-9606a
Experimental group
Description:
Participants who will receive an intravenous (IV) dose of DS9606a starting at 0.016 mg/kg every 3 weeks.
Treatment:
Drug: DS-9606a
Dose Expansion: Cohort B-1
Experimental group
Description:
Participants with ovarian cancer who will receive an intravenous (IV) dose of DS9606a at the recommended dose for expansion (RDE) every 3 weeks.
Treatment:
Drug: DS-9606a
Dose Expansion: Cohort B-2
Experimental group
Description:
Participants with refractory germ cell tumors who will receive an intravenous (IV) dose of DS9606a at the recommended dose for expansion (RDE) every 3 weeks.
Treatment:
Drug: DS-9606a

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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