Solid Tumors
Conditions
Brief summary
A dose escalating phase Ia-b clinical trial of the IGF-1 receptor inhibitor AXL1717 in patients with advanced cancer. The objective is to study the safety and pharmacokinetics of AXL1717 and to define an appropriate Phase 2 dose for further studies. This is the first study in man. The study is not designed to show tumor response.
Interventions
DRUGAXL1717
Phase I study with increasing dosage and treatment duration
Sponsors
Axelar AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age. 2. Histologically confirmed diagnosis of advanced solid or haematological malignancy not amenable to standard treatment. 3. Pharmacological treatment attempt justified 4. Preserved major organ functions, i.e: * B-Leukocyte count ≥ 3.0 x 109/L * B-Neutrophil count ≥ 1.5 x 109/L * B-Platelet count ≥ 75 x109/L * B-Haemoglobin ≥ 100 g/L (transfusions are allowed) * P-Total bilirubin level ≤ 1.5 times the upper institutional limit of the normal (i.e. reference) range * P-ASAT or P-ALAT ≤ 2.5 times upper institutional limit of the normal range, ≤5 times if liver metastases have been documented * P-Creatinine ≤ 1.5 times upper institutional limit of the normal range 5. Females of childbearing potential should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period. 6. Signed written informed consent.
Exclusion criteria
1. Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient 2. Known malignancy in CNS 3. Prior anti-tumour therapy within 4 weeks from enrolment (6 weeks for nitrosurea and MitC). 4. Pregnancy or lactation 5. Current participation in any other interventional clinical trial 6. Performance status \> ECOG 2 after optimization of analgesics 7. Life expectancy less than 3 months 8. Contraindications to the investigational product, e.g. known or suspected hypersensitivity. 9. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To define and confirm recommended Phase 2 dose | — |
Countries
Sweden
Outcome results
None listed