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Brief Title: Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors

A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: SC103
  • Secondary ID: N/A
  • NTC ID: NCT04234113
  • Sponsor: SOTIO a.s.

BRIEF SUMMARY

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

DETAILED DESCRIPTION

This study will assess the safety and tolerability of SO-C101 administered as monotherapy and in combination with an anti-PD-1 antibody (pembrolizumab) in patients with selected relapsed/refractory advanced/metastatic solid tumors (renal cell carcinoma, non-small cell lung cancer, small-cell lung cancer, bladder cancer, melanoma, Merkel-cell carcinoma, skin squamous-cell carcinoma, microsatellite instability high solid tumors, triple-negative breast cancer, mesothelioma, thyroid cancer, thymic cancer, cervical cancer, biliary track cancer, hepatocellular carcinoma, ovarian cancer, gastric cancer, head and neck squamous-cell carcinoma, and anal cancer).

  • Overall Status
    Recruiting
  • Start Date
    June 13, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part A;Number of Participants With Dose-Limiting Toxicities (DLT):

Primary Outcome 1 - Timeframe: Through Cycle 1 (a cycle is 21 days]

Primary Outcome 2 - Measure: Part A;Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Primary Outcome 2 - Timeframe: Cycle 1, Day 1 (each cycle is 21 days) through study completion an average of 1 year

Primary Outcome 3 - Measure: Part A;Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs

Primary Outcome 3 - Timeframe: assessed in average of 7 months

Primary Outcome 4 - Measure: Part A;Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0

Primary Outcome 4 - Timeframe: assessed in average of 7 months

Primary Outcome 5 - Measure: Part A;Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0: Biochemistry and Hematology

Primary Outcome 5 - Timeframe: Cycle 1 Day 1 (each cycle is 21 days) through study completion, an average of 1 year

Primary Outcome 6 - Measure: Part A;Number of Participants With Laboratory Test Abnormalities: Urinalysis

Primary Outcome 6 - Timeframe: Cycle 1 Day 1, (each cycle is 21 days) through study completion, an average of 1 year

Primary Outcome 7 - Measure: Part A;Number of Participants With Clinically Significant Change From Screening in Vital Signs

Primary Outcome 7 - Timeframe: Screening, through study completion, an average of 1 year

Primary Outcome 8 - Measure: Part A; Number of Participants With Eastern Cooperative Oncology Group [ECOG] Performance Status Score

Primary Outcome 8 - Timeframe: Screening, through study completion, an average of 1 year

Primary Outcome 9 - Measure: Part B: Number of Participants With Dose-Limiting Toxicities (DLT): Dose Finding Phase

Primary Outcome 9 - Timeframe: Cycle 1 Day 1 to Cycle 2 Day 1 21 days

Primary Outcome 10 - Measure: Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events

Primary Outcome 10 - Timeframe: Cycle 1 Day 1, up to 90 days after last dose of study drug (assessed in average of 7 months

Primary Outcome 11 - Measure: Part B: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events

Primary Outcome 11 - Timeframe: Cycle 1 Day 1, up to 90 days after last dose of study drug (assessed in average of 7 months

Primary Outcome 12 - Measure: Part B: Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0

Primary Outcome 12 - Timeframe: Cycle 1 Day 1, (each cycle is 21 days) through study completion, an average of 1 year

Primary Outcome 13 - Measure: Part B: Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0: Biochemistry and Hematology

Primary Outcome 13 - Timeframe: Cycle 1 Day 1, (each cycle is 21 days) through study completion, an average of 1 year

Primary Outcome 14 - Measure: Part B: Number of Participants With Laboratory Test Abnormalities: Urinalysis

Primary Outcome 14 - Timeframe: Screening, through study completion, an average of 1 year

Primary Outcome 15 - Measure: Part B: Number of Participants With Clinically Significant Change From Screening in Vital Signs

Primary Outcome 15 - Timeframe: Screening, through study completion, an average of 1 year

Primary Outcome 16 - Measure: Part B: Number of Participants With Eastern Cooperative Oncology Group [ECOG]

Primary Outcome 16 - Timeframe: Screening, through study completion, an average of 1 year

CONDITION

  • Thyroid
  • Renal Cell Carcinoma
  • Non Small Cell Lung Cancer
  • Small-cell Lung Cancer
  • Bladder Cancer
  • Melanoma
  • Merkel Cell Carcinoma
  • Skin Squamous Cell Carcinoma
  • Microsatellite Instability High
  • Triple Negative Breast Cancer
  • Mesothelioma
  • Thymic Cancer
  • Cervical Cancer
  • Biliary Tract Cancer
  • Hepatocellular Carcinoma
  • Ovarian Cancer
  • Gastric Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Anal Cancer

ELIGIBILITY

Inclusion Criteria:
Patients with selected histologically or cytologically confirmed advanced and/or metastatic solid tumors who are refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.

- ECOG performance score 0-1. Patients with ECOG is 2 to be discussed with the sponsor's medical monitor to be agreed for inclusion.

- Estimated life expectancy of ≥3 months

- Washout periods: 4 weeks for chemotherapy, 4 weeks or 5 half-lives (whichever shorter) for biologic agents including immuno-oncology therapy and 4 weeks from major surgeries, definitive radiotherapy and 2 weeks after palliative radiotherapy

- At least one measurable lesion per iRECIST in a non-irradiated port. If in a previously irradiated port, must have demonstrated progression since best response to radiation therapy.

- Have fully recovered from previous treatment to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy

- Adequate organ system function

- Negative serum pregnancy test, if woman of child-bearing potential (WOCBP; non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).

- Accessible tumor tissue available for fresh biopsy
Exclusion Criteria:
Key exclusion criteria (Part A and B)
Patient with untreated CNS metastases and/or leptomeningeal carcinomatosis (see list of all exclusion criteria for details)

- Known additional malignancy that is progressing and/or requires active treatment.

- Prior exposure to drugs that are agonists of IL-2- or IL-15-like but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar)

- History of and current interstitial lung disease or fibrosis and pneumonitis; patients with clinically significant or oxygen requiring COPD or any chronic inflammatory disease (sarcoidosis etc.)

- Has received a live vaccine within 30 days of planned start of study therapy (see list of all exclusion criteria for details)

- Absolute WBC count ≤ 2.0 ×109/L;

- ALC ≤0.5×109/L

- Absolute neutrophil count ≤1.0 ×109/L

- Platelet count ≤100×109/L

- Pregnant or breastfeeding women

- Any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma, or history of syndrome that required systemic steroids (except the allowed doses) or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy (see list of all exclusion criteria for details)

- Specific co-morbidities (see list of all exclusion criteria for details)

- Is hypersensitive to any of the ingredients of pembrolizumab drug product (KeytrudaTM)

- History of solid organ transplantation or hematopoietic stem cell transplantation

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: (+420) 2241 74448

Email: Kapsa@sotio.com

LOCATION

Facility Status Contact
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Filip Janku, MD, Pd.D
713-563-2632
FJanku@mdanderson.org
Facility: Institut Gustave Roussy
Paris, 94805
France
Status: Recruiting Contact: N/A
Facility: Vall d'Hebron Institute of Oncology
Barcelona, 08035
Spain
Status: Recruiting Contact: N/A