A Phase I First-in-Human Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD8701 Administered Intravenously as Monotherapy and in Combination With Durvaluamb (MEDI4736) in Participants With Advanced Solid Tumours.

  • STATUS
    Recruiting
  • End date
    Jan 22, 2024
  • participants needed
    153
  • sponsor
    AstraZeneca
Updated on 23 September 2022
ct scan
cancer
monoclonal antibodies
breast cancer
lung cancer
progressive disease
medi4736
durvalumab
solid tumour
triple negative breast cancer
squamous cell carcinoma of head and neck
lung carcinoma
small lung

Summary

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors

Description

This is a Phase I, First in Human, multicentre, open-label, multiple arm study with dose escalations and expansions at selected doses. Dose-escalation will occur with AZD8701 in monotherapy (Part 1) and in combination with durvalumab (Part 3) in selected participants with HNSCC, TNBC, NSCLC, ccRCC, gastroesophageal cancer, melanoma, cervical cancer, small-cell lung cancer and/or participants with solid tumours who have demonstrated a response to prior PD-(L)1 treatment.

Disease specific expansions will occur with a selected dose of AZD8701 in participants with NSCLC (Part 2) and with a selected dose of AZD8701 and durvalumab in participants with TNBC and clear cell RCC (Part 4).

Details
Condition Clear Cell Renal Cell Cancer, Non-Small-Cell Lung Cancer, Triple Negative Breast Neoplasms, Squamous Cell Cancer of Head and Neck, Small Cell Lung Cancer, Gastroesophageal Cancer, Melanoma, Cervical Cancer, Advanced Solid Tumours
Treatment durvalumab, AZD8701
Clinical Study IdentifierNCT04504669
SponsorAstraZeneca
Last Modified on23 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The study is comprised of 2 main parts Monotherapy (AZD8701) and Combined Therapy (AZD8701
and Durvalumab)
Inclusion criteria Dose escalation stages
Histological or cytological confirmation of a solid, malignant tumour including HNSCC
TNBC, NSCLC, ccRCC, gastroesophageal cancer, melanoma, cervical cancer, SCLC, and/or
Inclusion Criteria Dose Expansions
participants with other solid tumours who have demonstrated a response to prior
anti-PD-(L)1 treatment
Participant with progressive disease that is refractory to standard therapies or for
treatment
which no standard therapies exist and a clinical trial is the best option for next
treatment based on prior response and/or tolerability to standard of care
General inclusion criteria
Non Small Lung Cancer Participants who have received prior PD(L)1 treatment. Clear Cell
Must be 18 year old at the time of screening
Renal Cancer Participants who have not received prior PD(L)1 treatment
Body weight > 35 kg
Triple negative Breast Cancer participants who have who have not received prior PD(L)1
Capable of giving signed informed consent
ECOG performance status of 0 to 1
A serum albumin > 30g/L
Life expectancy of > 12 weeks
Male and Female participants of childbearing potential must use effective methods of
contraception
Participants must provide a new or previous tumour sample
Adequate organ system functions
At least 1 lesion, that qualifies as a RECIST 1.1 target lesion at baseline. Tumour
assessment by CT scan or MRI must be performed within 28 days prior to treatment

Exclusion Criteria

History of allogeneic organ transplantation
Significant cardiac disease
History of another primary malignancy except for
non-melanoma skin cancer
A condition that, in the opinion of the Investigator, would interfere with evaluation
Adequately treated carcinoma in situ without evidence of disease
of the study intervention or interpretation of participant safety or study results
Any major unresolved toxicity from previous anticancer therapy
Active or prior documented autoimmune or inflammatory disorders Uncontrolled
Prior/Concomitant Therapy
intercurrent illness
Participants who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4
Malignancy treated with curative intent and with no known active disease ≥ 5
years
Participant with previous or confirmed Covid 19 diagnosis requiring significant
medical intervention
Current clinical signs and symptoms consistent with COVID-19 or confirmed current
infection by appropriate laboratory test within the last 4 weeks prior to screening
Known allergy or hypersensitivity to any of the study interventions or any of the
study intervention excipients
Major surgical procedure within 28 days prior to the first dose
Receipt of the last dose of anticancer therapy within 5 half-lives or ≤ 21 days prior
to the first dose of study
Prior treatment with potential Treg depletion therapies including agents targeting
OX40 or CD357 (GITR) for 90 days prior to enrolment on study
Must not have experienced a toxicity that led to permanent discontinuation of
prior immunotherapy
All AEs while receiving prior immunotherapy must have completely resolved or
resolved to baseline
Must not have experienced a ≥ Grade 3 imAE or a neurologic or ocular imAE of any
grade while receiving prior immunotherapy
Must not have required the use of additional immunosuppression other than
corticosteroids for the management of an AE
Current or prior use of immunosuppressive medication within 14 days before the first
dose of study drug. b. The following are exceptions to this criterion
Intranasal, inhaled, topical steroids, or local steroid injections (eg
intra-articular injection)
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions (eg, CT scan
premedication)
Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy
for cancer treatment
Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of
radiation within 4 weeks of the first dose of study intervention
Participants receiving anticoagulation therapy with vitamin K antagonists (eg
Participation in another clinical study with study intervention administered in the
warfarin)
last 30 days
Female participants who are pregnant or breastfeeding or male and female participants
of reproductive potential who are not willing to employ effective birth control
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