๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
For the ASP388B monotherapy dose escalation (excluding the tumor-specific backfill participants), the following criteria apply:
* 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
* For mCRPC
* Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (including but not limited to abiraterone, enzalutamide and/or apalutamide) and have failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen).
* Participants must have undergone bilateral orchiectomy or must be on continuous ADT with a GnRH agonist or antagonist.
* Total serum testosterone โค 50 ng/dL or 1.7 nmol/L
* Evidence of progressive disease, defined as โฅ 1 PCWG3 criteria: PSA level โฅ 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart; Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications; Appearance of โฅ 2 new lesions in bone scan
* Participants with mCRPC can be enrolled without measurable disease.
* For sqNSCLC
* Participants with known EGFR, ALK, ROS, BRAF or other actionable mutations are eligible if treated with mutation targeted therapy and have progressed, relapsed or discontinued treatment due to toxicity.
* For SCLC
* Metastatic or extensive stage (EC-SCLC)
For the ASP388B 2L+HNSCC monotherapy dose expansion (including the tumor-specific backfill participants from the monotherapy dose escalation), the following criteria apply:
* Participant has histologically or cytologically confirmed HNSCC.
* Tumors arising from the nasopharynx are excluded.
* Known PD-1/PD-L1 status and any HPV status is eligible.
* Participant has evidence of radiographic progression on or after the last regimen received.
* Participant has locally advanced or metastatic disease that is not amenable to curative intent treatment.
* Participant has progressed, relapsed or discontinued treatment due to toxicity after local guidelines/SOC regimen for locally advanced or metastatic disease, and has received โค 3 prior lines of anticancer therapy in the locally advanced or metastatic setting.
* Neoadjuvant or adjuvant cytotoxic regimens will count as a prior regimen if relapsed or progressed โค 6 months after completion.
* No prior exposure to B7-H3, STING agonist or TopI directed therapy is allowed.
For the ASP388B 2L+ESCC monotherapy dose expansion (including the tumor-specific backfill participants from the monotherapy dose escalation), the following criteria apply:
* Participant has histologically or cytologically confirmed ESCC.
* Known PD-1/PD-L1 status and any HER2 status is eligible.
* Participant has evidence of radiographic progression on or after the last regimen received.
* Participant has locally advanced or metastatic disease that is not amenable to curative intent treatment.
* Participant has progressed, relapsed or discontinued treatment due to toxicity after local guidelines/SOC regimen for locally advanced or metastatic disease, and has received โค 3 prior lines of anticancer therapy in the locally advanced or metastatic setting.
* Neoadjuvant or adjuvant cytotoxic regimens will count as a prior regimen if relapsed or progressed โค 6 months after completion.
* No prior exposure to B7-H3, STING agonist or TopI directed therapy is allowed.
For the ASP388B 1L HNSCC (Excluding NPC and Salivary Gland Tumors) combination therapy dose escalation and expansion (including the tumor-specific backfill participants from combination therapy dose escalation), the following criteria apply: (ASP388B + Pembrolizumab + Carboplatin + 5-FU):
* Participant has histologically or cytologically confirmed HNSCC excluding nasopharyngeal cancer (NPC) and salivary gland tumors.
* Known PD-1/PD-L1 status and any HPV status is eligible
* Participant has recurrent or metastatic disease that is incurable by local therapies.
* Participant has had no prior systemic therapy administered with the exception of systemic therapy completed \> 6 months prior if given as part of multimodal treatment with curative intent for nonmetastatic disease stages.
* No prior exposure to B7-H3, STING agonist or TopI directed therapy is allowed.
For the ASP388B 1L ESCC combination therapy dose escalation and expansion (including the tumor-specific backfill participants from combination therapy dose escalation), the following criteria apply: (ASP388B + Pembrolizumab + Oxaliplatin + 5-FU):
* Participant has histologically or cytologically confirmed ESCC.
* Known PD-1/PD-L1 status and any HER2 status is eligible
* Participant has had no prior systemic therapy administered with the exception of systemic therapy completed \> 6 months prior if given as part of multimodal treatment with curative intent for nonmetastatic disease stages.
* No prior exposure to B7-H3, STING agonist or TopI directed therapy is allowed.
For the ASP388B 1L ESCC combination therapy dose escalation and expansion
* Participant has a predicted life expectancy โฅ 12 weeks.
* Participant has at least 1 measurable lesion per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Participant has an ECOG performance status of 0 or 1.
* Participant has adequate organ function as indicated by laboratory values (If a participant has received a recent blood transfusion, the laboratory tests must be