An Open-Label, Dose-Escalation, Safety Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors
| Status: | Recruiting | 
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer | 
| Therapuetic Areas: | Oncology | 
| Healthy: | No | 
| Age Range: | 18 - Any | 
| Updated: | 11/2/2018 | 
| Start Date: | April 2016 | 
| End Date: | August 2019 | 
| Contact: | Incyte Corporation Call Center | 
| Phone: | 1.855.463.3463 | 
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors
This is an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in subjects with
advanced or metastatic solid tumors that will be conducted in 2 parts. Part 1 will determine
the pharmacologically active dose and/or maximum tolerated dose of INCAGN01876. Part 2 will
further evaluate the recommended dose determined in Part 1 in subjects with select tumor
types.
			advanced or metastatic solid tumors that will be conducted in 2 parts. Part 1 will determine
the pharmacologically active dose and/or maximum tolerated dose of INCAGN01876. Part 2 will
further evaluate the recommended dose determined in Part 1 in subjects with select tumor
types.
Inclusion Criteria:
- Locally advanced or metastatic disease; locally advanced disease must not be amenable
to resection with curative intent
- Part 1: Subjects with advanced or metastatic solid tumors
- Part 2: Subjects with advanced or metastatic adenocarcinoma of endometrium, melanoma,
non-small cell lung cancer, and renal cell carcinoma
- Subjects who have disease progression after treatment with available therapies that
are known to confer clinical benefit, or who are intolerant to treatment, or subjects
who refuse standard treatment
- Presence of measureable disease based on RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Exclusion Criteria:
- Laboratory and medical history parameters not within the protocol-defined range
- Receipt of anticancer medications or investigational drugs within protocol-defined
intervals before the first administration of study drug
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or
complications from prior surgical intervention before starting therapy
- Receipt of a live vaccine within 30 days of planned start of study therapy
- Active autoimmune disease
- Prior treatment with any tumor necrosis factor super family agonist
- Known active central nervous system metastases and/or carcinomatous meningitis
- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation
We found this trial at
    8
    sites
	
									330 Brookline Ave
Boston, Massachusetts 02215
	
			Boston, Massachusetts 02215
617-667-7000 
							
					Principal Investigator: Dr. Frank Hodi
			
						
										Phone: 617-632-9280
					
		Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...  
  
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									1211 Medical Center Dr
Nashville, Tennessee 37232
	
			Nashville, Tennessee 37232
(615) 322-5000 
							
					Principal Investigator: Dr. Dana Cardin
			
						
										Phone: 615-875-7143
					
		Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...  
  
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									450 Brookline Ave
Boston, Massachusetts 2215
	
			Boston, Massachusetts 2215
617-632-3000 
							
					Principal Investigator: Dr. Frank Hodi
			
						
										Phone: 617-632-6287
					
		Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...  
  
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									500 Westchester Avenue
Harrison, New York 10604
	
			
					Harrison, New York 10604
Principal Investigator: Dr. James Harding
			
						
										Phone: 646-888-4440
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								Los Angeles, California 90025			
	
			
					Principal Investigator: Dr. Omid Hamid
			
						
										Phone: 310-231-2115
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								Middletown, New Jersey 07748			
	
			
					Principal Investigator: Dr. James Harding
			
						
										Phone: 646-888-4440
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								New Haven, Connecticut 6520			
	
			(203) 432-4771 
							
					Principal Investigator: Dr. LoRusso
			
						
										Phone: 203-737-1889
					
		Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...  
  
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									1275 York Ave
New York, New York 10021
	
			New York, New York 10021
(212) 639-2000
							
					Principal Investigator: Dr. James Harding
			
						
										Phone: 646-888-4440
					
		Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...  
  
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