A Study of ASP1002 in Adults for Treatment of Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstellas Pharma Global Development, Inc.
About this trial
The main aims of this study are:
* To check the safety of ASP1002 in people with certain solid tumors. * To check if the people can tolerate ASP1002. * To find a suitable dose of ASP1002. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP1002. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP1002 to use in Part 2 of the study.
In Part 2, other different small groups of people will receive doses of ASP1002 that worked the best in Part 1.
People in this study will be adults with metastatic or locally advanced solid tumors with high levels of a protein called claudin 4. The people's cancer will have either spread to other parts of the body (metastatic) or spread to tissue close by (locally advanced).
They will have been previously treated with available standard therapies or refused to receive those treatments.
In both parts of the study, ASP1002 (the study treatment) will be given to people slowly through a tube into a vein. This is called an infusion. This will happen every week, every other week, or every 3 weeks, in treatment cycles. Treatment cycles may be 21 days or 28 days long. People in this study will continue treatment for up to 2 years until: they have medical problems that prevent them from continuing treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; they do not come back for treatment.
During the study, people will visit the clinic several times for a health check. This includes standard safety checks and reporting any medical problems. Every few weeks, the study doctors will check if each person's cancer has stayed the same or got worse. This will be done by scans (CT or MRI scans). Tumor samples will be taken during the study and people will have the option of giving a tumor sample after treatment has finished.
People will visit the clinic within 7 days after stopping treatment for a health check. Then, they may visit the clinic at 1 month and 3 months after stopping treatment for further health checks. People will have follow-up health checks for up to 1 year after their last dose of ASP1002.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has locally-advanced (unresectable or metastatic solid tumor which is confirmed by available pathology records or current biopsy.
TNBC defined as unequivocal TNBC histology (ER 1 negative/progesterone receptor-negative/HER2-negative). This is defined by < 1% expression of ER and progesterone receptor by IHC and that are, for HER2, either 0 to 1+ by IHC, or IHC 2+ and FISH negative (not amplified) as per current ASCO/CAP guidelines [Hammond et al, 2010].
Not a woman of childbearing potential (WOCBP)
WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 90 days after final study intervention administration.
Disqualifiers
Participant weighs < 40 kg.
Participant has ongoing toxicity >/= grade 2 per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 considered clinically significant and attributable to prior antineoplastic therapies.
Participant has symptomatic CNS metastases or evidence of uncontrolled CNS disease even if asymptomatic (e.g. progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention and are not requiring immunosuppressive doses of systemic steroids (equivalent to > 10 mg per day of prednisone) for longer than 2 weeks.
Participant has an active autoimmune disease. Participant with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed.
Trial design
Design model
Sequential
Treatments tested in this trial
ASP1002
Drugintravenous (IV) infusion
Treatment groups
210 Participants
are divided into 4 treatment groupsGroup A: ASP1002 Dose Escalation (Part 1)Experimental treatment 1 intervention
Group B: ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)Experimental treatment 1 intervention
Group C: Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC)Experimental treatment 1 intervention
Group D: Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Dose Limiting Toxicities (DLTs) for ASP1002
A DLT is defined as any of the following AEs that the investigator (or sponsor) cannot clearly attribute to a cause other than study intervention.
Time frame
Up to 24 months2
Number of participants with Adverse Events (AEs)
Adverse events (AEs) will be coded using MedDRA. 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.
Time frame
Up to 25 months3
Number of participants with Serious Adverse Events (SAEs)
A Serious Adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important event.
Time frame
Up to 27 months4
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 27 monthsSecondary outcomes
1
Pharmacokinetics (PK) of ASP1002 in serum: AUC0-7d
AUC from the time of dosing to 7 days postdose (AUC0-7d) will be recorded from the PK serum samples collected.
Time frame
Up to 12 months2
Pharmacokinetics (PK) of ASP1002 in serum: Cmax
Maximum concentration (Cmax) will be recorded from the PK serum samples collected.
Time frame
Up to 12 months3
Pharmacokinetics (PK) of ASP1002 in serum: Ctrough
Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the PK serum samples collected.
Time frame
Up to 12 months4
Pharmacokinetics (PK) of ASP1002 in serum: tmax
Time of maximum concentration (tmax) will be recorded from the PK serum samples collected.
Time frame
Up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov