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Clinical Trial 20173

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03961698

Phase: Phase II
Principal Investigator: Soliman, Hatem

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Study Title

A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma


This is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC).


Primary Objectives: To evaluate the complete response (CR) rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(1) following combination treatment with IPI-549 and front-line treatment in patients with TNBC and RCC. Secondary Objectives: To evaluate the safety of combination treatment with IPI-549 and front-line treatment in patients with TNBC and RCC. To evaluate objective response rate (ORR), time to CR (TTCR), time to response (TTR), duration of CR (DOCR), duration of response (DOR), and progression-free survival (PFS) following combination treatment with IPI-549 and front-line treatment. To evaluate the pharmacokinetics (PK) of IPI-549 administered in combination with front-line treatment.



Therapy (NOS)


Atezolizumab (Tecentriq); Avastin (Bevacizumab); Bevacizumab (); IPI-549 (); Nab-paclitaxel (Abraxane)

Inclusion Criteria

  • at least 18 years of age
  • At least 1 measurable disease lesion by CT or MRI as defined by RECIST v1.1 performed within preferably 2 weeks prior to first dose. Should this be logistcally infeasible, a window of no more than 4 weeks (30 days) prior to first dose will be permissible. Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.
  • Willing to undergo one pre-treatment core biopsy (unless archival tumor tissue is available within 3 months of first dose) and one on-treatment tumor biopsy
  • Evaluable tumor tissue must be provided for biomarker analysis
  • Life expectancy 12 weeks or more
  • Must meet baseline laboratory values defined per protocol
  • Women of childbearing potential must have a negative pregnancy test within 1 week before administration of study drug serum
  • Women must not be breastfeeding
  • Willingness of male and female patients who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of study treatment, including 30 days after the last dose of IPI-549 and of nab-paclitaxel, or 6 months after the last dose of atezolizumab or bevacizumab, whichever is later. Male patients must refrain from donating sperm for these same periods. Male patients with a pregnant female partner must agree to remain abstinent or use a condom during the treatment period and for the duration of the pregnancy.
  • Patients in Cohort A must meet the following additional criteria for inclusion:
  • Women with metastatic or locally advanced, histologically documented TNBC, i.e., absence of HER2, estrogen and progesterone receptor expression:
  • HER2 negativity defined as either of the following by local laboratory assessment
  • ER and PR negativity defined as >No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC. Radiation therapy for metastatic disease is permitted. There is no required minimum washout period for radiation therapy. Patients should be recovered from the effects of radiation. Prior chemotherapy (including taxanes) in the neoadjuvant or adjuvant setting is allowable if treatment was completed 12 months or more prior to first treatment, while patients who have received prior non-taxane neoadjuvant/adjuvant chemotherapy 6-12 months prior to C1D1 may be considered for enrollment after consultation with medical monitor.
  • Patients in Cohort B must meet the following additional criteria for inclusion:
  • Men or women with histologically documented unresectable advanced or metastatic RCC with clear-cell histology
  • No prior treatment with active or experimental systemic agents, including treatment in the neoadjuvant or adjuvant setting. Prior radiotherapy is permitted but must not have been administered within 14 days of Cycle 1, Day 1

  • Exclusion Criteria

  • Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the patient to receive protocol therapy, or interfere with the interpretation of study results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
  • Any history of brain or leptomeningeal metastases.
  • Significant cardiovascular disease, such as NYHA cardiac disease (Class II or greater), myocardial infarction within 3 months prior to first treatment at C1D1, unstable arrhythmias, or unstable angina. Patients with a known left ventricular ejection fraction >Baseline QT interval corrected with Fridericia's method (QTcF) >480 ms
  • Major surgical procedure within 4 weeks prior to enrollment or anticipation of the need for a major surgical procedure during the course of the study other than for underlying diagnosis. Placement of central venous access catheter(s) (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted.
  • Active tuberculosis
  • Ongoing systemic bacterial, fungal, or viral infections at Screening
  • Positive HIV test
  • Active hepatitis B or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
  • Dependence on continuous supplemental oxygen use.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. Patients with indwelling catheters (e.g., PleurX®) are allowed
  • Uncontrolled hypercalcemia (>1.5 mmol/L ionized calcium or calcium >12 mg/dL or corrected serum calcium >ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. Patients who are receiving denosumab must discontinue denosumab use and replace it with a bisphosphonate instead while on study. There is no required minimum washout period for denosumab. Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells, or any of the study drug components
  • History of severe reactions to chimeric or humanized antibodies or fusion proteins
  • History of stroke, transient ischemic attack, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to Screening
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan.
  • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Administration of a live or attenuated vaccine within 4 weeks of first dose of study drug
  • Prior therapy with experimental anti-tumor vaccines
  • Treatment with systemic immunostimulatory agents
  • Other exclusions apply

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