Detail

Basic Information Clinical Results Relationship Graph

Gene symbol	CSF2	Synonyms	CSF, GMCSF	Type of gene	protein-coding
Chromosome	5	Map location	5q31.1	dbXrefs
Gene perturbation-related omics dataset	PerturbAtlas
Description	colony stimulating factor 2

GTO ID	GTC4002
Trial ID	NCT02963831
Disease	Colorectal Cancer \| Ovarian Cancer \| Appendiceal Neoplasm
Altered gene	E1A\|CSF2
Therapeutic/Target gene	Therapeutic gene
Therapy	DNA oncolytic virus
Treatment	ONCOS-102\|CGTG-102
Co-treatment	Durvalumab\|cyclophosphamide
Phase	Phase1\|Phase2
Recruitment status	Completed
Title	A Phase 1/2 Dose Escalation Study With Expansion Cohorts to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
Year	2017
Country	United States
Company sponsor	Ludwig Institute for Cancer Research
Other ID(s)	LUD2015-008

Vector information

Vector	adenovirus
Construct	Ad5/3-delta24-GMCSF
Vector type	serotype 5 adenovirus
Transgene/Inserted gene	GM-CSF, which enhances antitumor immunity by recruiting antigen-presenting cells (APCs) and natural killer (NK) cells, activates and matures APCs at the tumor site, thereby potentiating the ability of ONCOS-102 to induce cellular immunity against the tumor in which it replicates.
Viral genome modification	ONCOS-102 has a genetically modified fiber with a serotype 3 knob for enhanced gene delivery to cancer cells. A 24-bp deletion has been made in the Rb binding site of the E1A gene.
Additional feature	GM-CSF

Cohort1: dose level 1_starting on day 1

Administration route	intraperitoneally infusion\|intravenous injection\|intravenous infusion
Dosage	ONCOS-102, 1E11 viral particles (VPs), starting on day 1\|Durvalumab, 1500 mg, Q4W for 12 cycles, starting on Day 15\|cyclophosphamide, 300 mg, 1 to 3 days before the first infusion of ONCOS-102
Pts	4
Age	Adult, Older_Adult
Adverse reactions	3/4(All-cause mortality); 3/4(Gastrointestinal disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified (incl cysts and polyps))

Cohort2: dose level 2_starting on day 15

Administration route	intraperitoneally infusion\|intravenous injection\|intravenous infusion
Dosage	ONCOS-102, 1E11 viral particles (VPs), starting on day 15\|Durvalumab, 1500 mg, every 4 weeks (Q4W) for 10 cycles, starting on Day 71\|cyclophosphamide, 300 mg, 1 to 3 days before the first infusion of ONCOS-102
Pts	5
Age	Adult, Older_Adult
Adverse reactions	3/5(All-cause mortality); 3/5(Cardiac disorders; Gastrointestinal disorders; General disorders; Neoplasms benign, malignant and unspecified (incl cysts and polyps); Nervous system disorders)

Cohort3: dose level 2_starting on day 15_Epithelial Ovarian Cancer

Administration route	intraperitoneally infusion\|intravenous injection\|intravenous infusion
Dosage	ONCOS-102, 3E11 viral particles (VPs), starting on day 15\|Durvalumab, 1500 mg, every 4 weeks (Q4W) for 10 cycles, starting on Day 71\|cyclophosphamide, 300 mg, 1 to 3 days before the first infusion of ONCOS-102
Pts	19
Age	Adult, Older_Adult
Adverse reactions	16/19(All-cause mortality); 9/19(Gastrointestinal disorders; General disorders; Infections and infestations; Neoplasms benign, malignant and unspecified (incl cysts and polyps); Nervous system disorders; Respiratory, thoracic and mediastinal disorders)

Cohort4: dose level 2_starting on day 15_Metastatic Colorectal Cancer

Administration route	intraperitoneally infusion\|intravenous injection\|intravenous infusion
Dosage	ONCOS-102, 3E11 viral particles (VPs), starting on day 15\|Durvalumab, 1500 mg, every 4 weeks (Q4W) for 10 cycles, starting on Day 71\|cyclophosphamide, 300 mg, 1 to 3 days before the first infusion of ONCOS-102
Pts	36
Age	Adult, Older_Adult
Adverse reactions	28/36(All-cause mortality); 22/36(Cardiac disorders; Gastrointestinal disorders; General disorders; Infections and infestations; Metabolism and nutrition disorders; Neoplasms benign, malignant and unspecified (incl cysts and polyps); Nervous system disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

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