Safety, Tolerability, PK, Dosimetry, MTD and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by IV Escalating Doses of [177Lu]DOTA-biotin in Pts With Injectable Solid Tumors or Lymphomas

PHASE1TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

August 7, 2017

Primary Completion Date

June 30, 2019

Study Completion Date

July 1, 2019

Conditions
Inoperable Solid Tumors or Lymphomas
Interventions
DRUG

AvidinOX

"AvidinOX vial containing 22.5 mg AvidinOX~\+ vials containing 10 ml of water for injection (WFI) for the reconstitution in a clear solution with an AvidinOX concentration of 3 mg/ml. One Intralesion administration of a volume of reconstituted AvidinOX equal to about 15 % of the estimated lesion volume"

DRUG

177Lu-ST2210

177Lu-ST2210 dose starting at 7.5 Gigabequerel (GBq) ±10%with escalation steps of 2.5 GBq up to 15 GBq ±10%, approximately 1 mg ST2210

DRUG

177Lu-ST2210

Second dose of 177Lu-ST2210 dose (14 days after the first dose) starting at 7.5 Gigabequerel (GBq) ±10%with escalation steps of 2.5 GBq up to 15 GBq ±10%, approximately 1 mg ST2210

Trial Locations (1)

77030

Dep. of Investigational Cancer Therapeutics - U. T. M. D. Anderson Cancer Center, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alfasigma S.p.A.

INDUSTRY

NCT03188328 - Safety, Tolerability, PK, Dosimetry, MTD and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by IV Escalating Doses of [177Lu]DOTA-biotin in Pts With Injectable Solid Tumors or Lymphomas | Biotech Hunter | Biotech Hunter