A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer (NCT02797964) | Clinical Trial Compass
CompletedPhase 1/2
A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer
United Kingdom107 participantsStarted 2016-07
Plain-language summary
The purpose of this clinical study is to establish the safety profile, determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose and schedule of SRA737; and to evaluate the efficacy of SRA737 in prospectively-selected subjects with genetically-defined tumors that harbor genomic alterations linked to increased replication stress and that are hypothesized to be more sensitive to checkpoint kinase 1 (Chk1) inhibition via synthetic lethality. Specific cancer indications that frequently harbor these genetic mutations will be studied.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. For Dose Escalation Only: any locally advanced or metastatic, histologically or cytologically proven solid tumor or NHL, relapsed after or progressing despite conventional treatment
✓. Life expectancy of at least 12 weeks
✓. World Health Organization (WHO) performance status of 0-1
✓. Must meet select hematological and biochemical laboratory indices
✓. Archival tumor tissue or accessible tumor and willingness to consent to a biopsy
✓. Any locally advanced or metastatic malignancy of the following types for which no other conventional therapy is considered appropriate:
✓. Measurable disease per RECIST v1.1, or for mCRPC, evaluable disease per any of the following:
✓. Tumor tissue or ctDNA evidence that subject's tumor harbors a combination of mutations which are expected to confer sensitivity to Chk1 inhibition. Eligibility will be determined by the Sponsor's review of genetic abnormalities detected in genes in the following categories:
Exclusion criteria
✕. Received the following prior or current anticancer therapy:
✕. Other malignancy within the past 2 years, except for adequately treated tumors
✕. Ongoing toxic manifestations of previous treatments greater than NCI-CTCAE Grade 1
What they're measuring
1
Number of Subjects With Adverse Events as Assessed by CTCAE 4.03
Timeframe: Up to 30 days after last dose of SRA737
2
Maximum Tolerated Dose of SRA737
Timeframe: Cycle 1 (28 days) in the Dose Escalation Phase
3
Recommended Phase 2 Dose of SRA737
Timeframe: Up to 30 days after last dose of SRA737
4
Disease Control Rate (DCR) of SRA737
Timeframe: Radiographic tumor assessments were performed every 2 cycles of therapy.
5
Time to Progression (TTP)
Timeframe: Radiographic tumor assessments were performed every 2 cycles of therapy. Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.
6
Progression Free Survival (PFS)
Timeframe: Radiographic tumor assessments were performed every 2 cycles of therapy. Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.
7
Overall Survival (OS)
Timeframe: Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.
. For Dose Escalation: new or progressing brain metastases. For Cohort Expansion: present or prior brain metastases
✕. High medical risk because of nonmalignant systemic disease
✕. Serologically positive for hepatitis B, hepatitis C or HIV
✕. Serious cardiac condition, left ventricular ejection fraction \< 45% at baseline, history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment
✕. Prior bone marrow transplant or extensive radiotherapy to greater than 25% of bone marrow within 8 weeks