CompletedPhase 1

Phase 1 Study of Oral TP-1454

United States31 participantsStarted 2020-07-08

Plain-language summary

This study will evaluate the safety and tolerability of oral TP-1454 in patients with advanced metastatic or progressive solid tumors and anal cancer.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients to be enrolled during Dose Escalation with capsules must have a histologically confirmed diagnosis of advanced metastatic or progressive solid tumor who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition (enrollment complete).
✓. Following approval of Amendment 5.0, patients to be enrolled during Dose Escalation with Tablets must have a histologically confirmed diagnosis of anal cancer and:
✓. have received at least one line of systemic platinum-based therapy in the advanced setting; (Note: Systemic platinum therapy given in the adjuvant setting will meet this criterion if there is recurrence or metastasis within 6 months of completing adjuvant therapy.); and
✓. have received no more than 3 total lines of systemic therapy in the advanced setting.
✓. Have measurable disease as outlined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
✓. Be ≥18 years of age
✓. Have a negative pregnancy test (if female of childbearing potential)

Exclusion criteria

✕. New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months or evidence of ischemia on electrocardiogram (ECG) within 14 days prior to Cycle 1/Day 1
✕. Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>450 msec in men and \>470 msec in women
✕. Have a seizure disorder requiring anticonvulsant therapy
✕. Have untreated central nervous system (CNS) metastases including carcinomatous meningitis. Patients with definitively treated (radiotherapy or surgery) CNS metastases may be eligible if asymptomatic and not receiving corticosteroids in excess of prednisone 10 mg (or equivalent) per day for ≥2 weeks before first dose of TP-1454
✕. Have hypoxemia (defined as resting O2 saturation of ≤90% breathing room air)
✕. Have symptomatic interstitial lung disease
✕. Have undergone major surgery within 2 weeks prior to Cycle 1/Day 1
✕. Have active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

What they're measuring

Determine maximum tolerated dose (MTD)

Timeframe: 50 months

Determine recommended Ph2 dose (RP2D) of TP-1454

Timeframe: 50 months

Incidence of SAEs and AEs resulting in study discontinuation, as assessed by NCI NTCAE v5.0

Timeframe: From date of treatment through 30 days after End of Treatment, an average of 6 months

Trial details

NCT IDNCT04328740

SponsorSumitomo Pharma America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-25

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients to be enrolled during Dose Escalation with capsules must have a histologically confirmed diagnosis of advanced metastatic or progressive solid tumor who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition (enrollment complete).
✓. Following approval of Amendment 5.0, patients to be enrolled during Dose Escalation with Tablets must have a histologically confirmed diagnosis of anal cancer and:
✓. have received at least one line of systemic platinum-based therapy in the advanced setting; (Note: Systemic platinum therapy given in the adjuvant setting will meet this criterion if there is recurrence or metastasis within 6 months of completing adjuvant therapy.); and
✓. have received no more than 3 total lines of systemic therapy in the advanced setting.
✓. Have measurable disease as outlined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
✓. Be ≥18 years of age
✓. Have a negative pregnancy test (if female of childbearing potential)

Exclusion criteria

✕. New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months or evidence of ischemia on electrocardiogram (ECG) within 14 days prior to Cycle 1/Day 1
✕. Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>450 msec in men and \>470 msec in women
✕. Have a seizure disorder requiring anticonvulsant therapy
✕. Have untreated central nervous system (CNS) metastases including carcinomatous meningitis. Patients with definitively treated (radiotherapy or surgery) CNS metastases may be eligible if asymptomatic and not receiving corticosteroids in excess of prednisone 10 mg (or equivalent) per day for ≥2 weeks before first dose of TP-1454
✕. Have hypoxemia (defined as resting O2 saturation of ≤90% breathing room air)
✕. Have symptomatic interstitial lung disease
✕. Have undergone major surgery within 2 weeks prior to Cycle 1/Day 1
✕. Have active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

What they're measuring

Determine maximum tolerated dose (MTD)

Timeframe: 50 months

Determine recommended Ph2 dose (RP2D) of TP-1454

Timeframe: 50 months

Incidence of SAEs and AEs resulting in study discontinuation, as assessed by NCI NTCAE v5.0

Timeframe: From date of treatment through 30 days after End of Treatment, an average of 6 months