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BRIEF TITLE: 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

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


  • Org Study ID: SC103
  • Secondary ID:
  • NCT ID: NCT04234113
  • NCT Alias:
  • Sponsor: Sotio a.s. - Industry
  • Source: 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).

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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

Criteria:
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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Richard Kapsa

Phone: (+420) 2241 74448

Email: Kapsa@sotio.com

Locations

Facility Status Contact
Yale Cancer Center
New Haven, Connecticut 06520
United States
Not yet recruiting Patricia LoRusso, MD, Ph.D
203-785-5944
patricia.lorusso@yale.edu
MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Filip Janku, MD, Pd.D
713-563-2632
FJanku@mdanderson.org
Institut Gustave Roussy
Paris, 94805
France
Recruiting
Vall d'Hebron Institute of Oncology
Barcelona, 08035
Spain
Recruiting