First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

STATUS

Recruiting
End date

Jan 22, 2024
participants needed

153
sponsor

AstraZeneca

Send

Updated on 9 June 2022

See if I qualify

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 Identifier	NCT04504669
Sponsor	AstraZeneca
Last Modified on	9 June 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

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
	CTLA-4 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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

ct scan

cancer

monoclonal antibodies

triple negative breast cancer

squamous cell carcinoma of head and neck

lung carcinoma

small lung

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours