FIH XON7 in Advanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorXenothera SAS
About this trial
This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide signed, written informed consent.
Male and female participant, age ≥ 18 years old (at the time consent is obtained)
Participant in phase I, must have a histologically or cytologically confirmed advanced or metastatic solid tumors for which no effective standard therapy is available. All tumor types except glioblastoma, could be included.
Participant in phase II, must have histologically or cytologically confirmed advanced or metastatic solid tumors of the following: NSCLC, gastro-esophageal adenocarcinoma, CRC, pancreatic cancer, Sarcoma, TNBC, or ovarian cancer.
Disqualifiers
A participant who has received more than 4 prior lines of therapy for advanced or metastatic disease.
A participant who has had a prior anti-cancer mAb within 3 weeks prior to trial Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier prior to trial Day 1.
A participant who has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial Day 1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (Except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy).
A participant with ≥Grade 3 toxicity related to prior immunotherapy leading to treatment discontinuation.
Trial design
Design model
Single group
Treatments tested in this trial
XON7
DrugThe trial intervention (XON7) is a glyco-humanized polyclonal antibody drug which is formulated for intravenous (IV) administration
Treatment groups
255 Participants
are divided into 1 treatment groupGroup A: Dose Escalation part then Expansion partExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Escalation part: Dose Limiting Toxicities (DLTs)
Investigator defined DLT during first treatment cycle
Time frame
At the end of Cycle 1 (28 days)2
Dose Escalation part: treatment emergent adverse events (TEAEs)
An overall summary of AE occurrences with onset during the first treatment cycle will be presented; this will include the following AE attributes: * Preferred term, * Maximum CTCAE grade, * Outcome, * Time to first occurrence \[days\].
Time frame
At the end of Cycle 1 (28 days)3
Dose Escalation part: clinically significant changes in Leucocytes count
Incidence and magnitude of clinically significant changes in Leucocytes Count (G/L)
Time frame
At the end of Cycle 1 (28 days)4
Dose Escalation part: clinically significant changes in Red Blood Cells Count
Incidence and magnitude of clinically significant changes in Red Blood Cells Count (T/L)
Time frame
At the end of Cycle 1 (28 days)Secondary outcomes
1
Pharmacokinetics (PK) of XON7 (Part 1): Cmax
XON7 peak plasma concentration (Cmax) in plasma
Time frame
Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion2
Pharmacokinetics (PK) of XON7 (Part 2): Cmax
XON7 peak plasma concentration (Cmax) in plasma
Time frame
Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion3
Pharmacokinetics (PK) of XON7 (Part 1): Tmax
Time to peak drug concentration in plasma (Tmax)
Time frame
Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion4
Pharmacokinetics (PK) of XON7 (Part 2): Tmax
Time to peak drug concentration in plasma (Tmax)
Time frame
Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusionSponsors and contacts
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Source ClinicalTrials.gov