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PhI D3S-001 Monotherapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation

Cancer
Misako Nagasaka
A Phase 1/2, Open-label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation
Anus
Bones and Joints
Brain and Nervous System
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Ill-Defined Sites
Kaposis sarcoma
Kidney
Larynx
Lip Oral Cavity and Pharynx
Liver
Lung
Melanoma skin
Mycosis Fungoides
Other Digestive Organ
Other Endocrine System
Other Female Genital
Other Male Genital
Other Respiratory and Intrathoracic Organs
Other Skin
Other Urinary
Ovary
Pancreas
Prostate
Rectum
Small Intestine
Soft Tissue
Stomach
Thyroid
Unknown Sites
Urinary Bladder

Study Description

Arm A - Volrustomig: Participants in the volrustomig arm will receive 750 mg IV on

Day 1 of each 21-day cycle for up to 12 months or 18 cycles, or until RECIST 1.1‑defined

radiological PD confirmed by investigator assessment, unless there is evidence of

unacceptable toxicity, or if a participant requests to stop the study intervention (for

discontinuation of study intervention/observation criteria, see Section 7.1). Approximately

573 participants will be treated with volrustomig 750 mg IV Q3W in this study

Arm B - Observation: Participants in the observation arm will undergo observation for up

to 12 months or until RECIST 1.1-defined radiological PD confirmed by investigator

assessment, or any study discontinuation criterion is met (for study discontinuation

criteria, see Section 7.1). Approximately 573 participants will be observed during this

study.

Eligibility

  1. Participants will have completed standard-of-care definitive cCRT with curative intent

within 12 weeks (84 days) prior to randomization as presented below. If baseline CT/MRI

images are equivocal and/or residual disease is suspected, investigators are strongly

recommended to perform an FDG-PET assessment to confirm absence of progression.

Where FDG-PET-avid lesions are detected and accessible, an endoscopy is recommended

to be performed and a biopsy taken as clinically indicated to confirm residual disease and

evaluate whether participation in this study is appropriate.

  1. Participants must not have progressed following definitive cCRT therapy with curative

intent. Absence of recurrence and/or progression will be assessed by the following

imaging procedures up to 12 weeks after the last dose of cCRT.

  1. Local disease (primary tumor site and neck) will be assessed by CT (preferred) or

MRI with contrast from mid-orbits to thoracic inlet.

  1. Absence of disease outside of the head and neck will be assessed by CT with contrast

(preferred) of the chest, abdomen including liver, and pelvis as clinically indicated or

by MRI if CT with IV contrast is contraindicated.

  1. Confirmation of PD-L1 expression from tumor tissue sample per Inclusion Criterion 4

(all participants) by the central laboratory. Participants with unknown PD-L1 expression

prior to randomization are not eligible for the study

  1. Adequate organ and bone marrow function (in the absence of transfusions or growth

factor support within 14 days prior to Screening Part II).

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