A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstellas Pharma Global Development, Inc.
About this trial
This is an early development study of ASP388B in people with solid tumors. In this study, ASP388B will be given to people for the first time. It will be given by itself or together with standard cancer therapies. The main aims of the study are to check the safety of ASP388B and find the most suitable dose.
This study will be in 2 parts. In Part 1, different small groups of people with solid tumors will receive lower to higher doses of ASP388B. Some groups will receive ASP388B by itself, and other groups will receive ASP388B with standard cancer therapies. Any medical problems will be recorded for each dose. This is to find suitable doses of ASP388B to use in Part 2 of the study, and to include the tumor types that responded well to ASP388B.
In Part 2, other different small groups of people with the specific tumor types (from Part 1) will receive the most suitable doses worked out from Part 1. Some groups will receive ASP388B by itself, and other groups will receive ASP388B with standard cancer therapies.
In both parts of the study, ASP388B will be given once in 3-week cycles. The standard cancer therapies will be given according to their approved label. ASP388B and the standard cancer therapies will be given slowly through a tube into a vein. This is called an infusion.
In both parts of the study, safety checks will be done at each visit, and the doctors will continue to check for medical problems throughout the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumors.
Participant has progressed on, is ineligible for, or has refused all available standard therapies (no limit to the number of prior treatment regimens).
Prior exposure to B7-H3, STING agonist or TopI directed therapy is allowed.
Participant must have one of the following malignancies (for all tumor types, any compounds of neuroendocrine histology is ineligible): HNSCC, ESCC, mCRPC, sqNSCLC, SCLC
Disqualifiers
Participant weighs < 40 kg during screening.
Participant has known active central nervous system (CNS) metastases. NOTE: A participant with CNS metastases who has been treated with surgery and/or radiation therapy, who is no longer taking pharmacologic doses of glucocorticoids and is neurologically stable, is eligible. Prophylactic use of anticonvulsants is permitted.
Any history of recurrent Grade 3 immune-related AEs (irAEs) or history of Grade 4 irAEs related to prior anticancer therapy.
Participant with type 1 diabetes mellitus
Trial design
Design model
Sequential
Treatments tested in this trial
ASP388B
DrugIntravenous infusion
Pembrolizumab
DrugIntravenous infusion
Carboplatin
DrugIntravenous infusion
Oxaliplatin
DrugIntravenous infusion
5-fluorouracil
DrugIntravenous infusion
Treatment groups
392 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: ASP388B Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: ASP388B Monotherapy Dose Expansion (HNSCC)Experimental treatment 1 intervention
Group C: ASP388B Monotherapy Dose Expansion (ESCC)Experimental treatment 1 intervention
Group D: ASP388B Combination Therapy Dose Escalation (HNSCC)Experimental treatment 4 interventions
Group E: ASP388B Combination Therapy Dose Escalation (ESCC)Experimental treatment 4 interventions
Group F: ASP388B Combination Therapy Dose Expansion (HNSCC)Experimental treatment 4 interventions
Group G: ASP388B Combination Therapy Dose Expansion (ESCC)Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Dose Limiting Toxicities (DLTs)
A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1) that cannot clearly be attributed to a cause other than ASP388B administered in monotherapy or in combination with standard treatments.
Time frame
Up to 21 days after C1D12
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures. A TEAE is an AE with onset at any time from first dosing until last scheduled procedure.
Time frame
Up to 45 months3
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Time frame
Up to 45 months4
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame
Up to 45 monthsSecondary outcomes
1
Objective Response Rate (ORR) of ASP388B per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR is defined as the proportion of participants whose best overall response with confirmation is rated as Complete Response (CR) or Partial Response (PR) per RECIST v1.1 as assessed by investigator. All tumor types except mCRPC.
Time frame
Up to 45 months2
Objective Response Rate (ORR) of ASP388B per Prostate Cancer Working Group 3 (PCWG3)
ORR is defined as the proportion of participants whose best overall response with confirmation is rated as Complete Response (CR) or Partial Response (PR) per PCWG3 guidance as assessed by the investigator. mCRPC only.
Time frame
Up to 45 months3
Duration of Response (DOR) of ASP388B per RECIST v1.1
DOR is for responders only. DOR is defined as the time from when the measurement criteria is first met for BOR rated as CR or PR (whichever is first recorded) until the first date of documented radiological disease progression by investigator per RECIST v1.1 or death in the absence of progression. All tumor types except mCRPC.
Time frame
Up to 45 months4
Duration of Response (DOR) of ASP388B per Prostate Cancer Working Group (PCWG3)
DOR is for responders only. DOR is defined as the time from when the measurement criteria are first met for BOR rated as CR or PR (whichever is first recorded) until the first date of documented radiological disease progression by investigator per PCWG3 guidance or death in the absence of progression. mCRPC only.
Time frame
Up to 45 monthsSponsors and contacts
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Source ClinicalTrials.gov